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Diagnostic devices · 21 CFR 872 Subpart B

Extraoral with Timer X-Ray Unit

FDA device type “Unit, X-Ray, Extraoral With Timer”.

FDA codeEHDClass221 CFR872.1800Pathway510(k)CategoryDental X-ray units
Companies listing it
5540 makers
Brands and models
121
510(k) clearances
19130 in five years
FDA name
Unit, X-Ray, Extraoral With Timer
1977: 11978: 31980: 21981: 11985: 11986: 31987: 41988: 31989: 11990: 11991: 21992: 21993: 71994: 31995: 21996: 71997: 141998: 51999: 72000: 112001: 32002: 62003: 92004: 82005: 82006: 22007: 12008: 52009: 42010: 42011: 32012: 22013: 42014: 32015: 12016: 22017: 42018: 52019: 42020: 22021: 12022: 82023: 82024: 72025: 12026: 619801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EHD

55 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Osstem Implant Co., Ltd.South KoreaMakerN1682026
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerAi Ray · Ai Ray Lite, Ai Ray Pro, Master Ray · Dental X-Ray Device122025
VATECH Co., Ltd.South KoreaMaker—332026
Cefla S.C.ItalyMakerRX DC152026
Genoray Co., Ltd.South KoreaMakerDVAS-M · DVAS-W · PORT-X II · PORT-X IV · +10142025
Digimed Co., Ltd.South KoreaMakerDhx-70h · DIOX-602 · Hybrid C70 · HYBRID Pro · +762023
Changzhou Sifary Medical Technology Co., Ltd.ChinaMakerHand-held Dental X-ray System (HyperLight-M) · HyperLight Portable X-ray Unit · HyperLight Pro Portable X-ray Unit42026
Guilin Refine Medical Instrument Co., LTD.ChinaMakerPortable Dental X-ray Device (Model: GT-1)32026
PaloDEx Group OyFinlandMakerFOCUS92024
Alliage S/A Industrias Medico OdontologicaBrazilMakerD700 SLIM · EAGLE S · EVOLVE SENSOR · Portable Dental X-Ray · +532024
Ningbo Runyes Medical Instrument Co., Ltd.ChinaMakerDiagnostic X-Ray Equipment MobileX R98 · Diagnostic X-Ray Equipment POCT22 · Diagnostic X-Ray Equipment RAY88(P) · Diagnostic X-Ray Equipment RAY98(P) · +222026
Dental Imaging Technologies CorporationUnited StatesMakerNOMAD Pro 2 · NOMAD Pro 322026
Shenzhen Xpectvision Technology Co., Ltd.ChinaMakerXpectVision, Handheld Dental X-ray System, XVbeam200022024
PICOPACK Inc.South KoreaMakerWeRay22024
iRay Imaging Technology (Haining) LimitedChinaMakerCanis014D0722023
Planmeca OyFinlandMakerPlanmeca ProMax · Planmeca ProSensor HD · Planmeca ProX252023
Midmark CorporationUnited StatesMakerPreva, Extraoral X-Ray System72025
De Götzen S.R.L.ItalyMakerx-mind dc · X-MIND unity62023
Hdx Will Corp.South KoreaMakerStar-X; Intraoral X-ray System · Xcam62021
Trident SRLItalyMaker—52023
Remedi Inc.South KoreaMakerMobileX T-100 · REMEX-GR100 · REMEX-T100 · T-10022024
Guangzhou Ajax Medical Equipment Co., Ltd.ChinaMakerDental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700)12026
VSI Co., Ltd.South KoreaMakerCLAROX · CLAROX X4 · X412022
DRTECH CorporationSouth KoreaMakerXERO ?12024
ECOTRON Co., Ltd.South KoreaMakerExtraoral source x-ray system DT-703, ProX Go12022
Lucas Lifecare, LLCUnited StatesMakerLifeRay Intraoral Handheld X-ray12024
PDX Co., Ltd.South KoreaMakernova12026
Carestream Dental LLCUnited StatesMakerCS 2100 · CS 2200112020
Takara Belmont CorporationJapanMakerPHOT-X II, MODEL 303 · PHOT-X-IIS Model 505 · 097 Bel-Ray II72017
Rolence Ent., Inc.TaiwanMakerExtraoral X-Ray Unit52009
Skanray Technologies LimitedIndiaMakerIMAGESCAN HD · INTRA SKAN DC · INTRASKAN DC · INTRASKAN DC PLUS · +132017
Livermoretech, Inc.United StatesMakerAIRTOUCH, PORTABLE X-RAY SYSTEM; EZER, PORTABLE X-RAY SYSTEM12019
Beyes Dental IncCanadaMakerDURAY V2 X-Ray Unit——
Ads Dental System Inc.United StatesMakerDental X-RAY Unit(Model:AJX200, AJX100, AJX300, AJX400, AJX500, AJX600, AJX700)——
XLINE S.r.l.ItalyMakerFONA XDC · IntraOs 70 · IntraOs DG · PantOs 16 xp · +3——
Dhef Inc.TaiwanMaker———
Poskom Co LtdSouth KoreaMakerREXTAR X · Xcam——
Turner Imaging SystemsUnited StatesMakerLumos 3DX——
Valkyrie BioScience, IncUnited StatesMakerLumos 3DX——
Nobel Biocare Services AGSwitzerlandContract manufacturerKaVo NOMAD942026
Young Innovations IncUnited StatesContract manufacturerPanoramic232025
Satelec - Acteon GroupUnited StatesManufacturerSopro PSPIX182024
DentamericaUnited StatesRepacker / relabeler—42010
Vector Research & DevelopmentUnited StatesRepacker / relabelerMaxRay W6812002
Apixia, Inc.United StatesRepacker / relabeler—12012
Sotera Health LLCUnited StatesContract manufacturer———
Jersey Dental SuppliesUnited StatesRepacker / relabelerNOMAD PRO X-RAY SYSTEM——
Nordent MFG., Inc.United StatesContract manufacturerAi Ray Lite——
Flight Dental Systems USA Inc.United StatesRepacker / relabelerX-Vision Portable Handheld X-Ray · XR-3800, XR-3801, XR-3802——
Toyo Medical Co.United StatesRepacker / relabelerTakara Belmont Co · Takara Belmont Corporation · TOYO MEDICAL CO · Toyo Medical Co.——
Owandy Radiology SASFranceRepacker / relabelerI-MAX Touch · Ow-RX · Owandy-RX DC · Owandy-RX PRO——
Orich Medical Equipment (Tianjin) Co., Ltd.ChinaForeign exporterIntra Os 70 · Intra OS DG · Panaramic——
RadmediX, LLCUnited StatesRepacker / relabelerAcuityDX+——
XRD Dental EquipmentUnited StatesListerXRD RAY98(P)——

510(k) clearances

Decided510(k)DeviceApplicant
14 Sep 2026K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.
27 May 2026K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.
20 Mar 2026K253864NOMAD Pro 3Dental Imaging Technologies Corporation
12 Mar 2026K252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.
19 Feb 2026K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., LTD.
3 Feb 2026K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.
4 Sep 2025K251438Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )Guilin Woodpecker Medical Instrument Co., Ltd.
4 Dec 2024K242185Rextar ProRaypia Co., Ltd.
1 Nov 2024K242591XERO-alphaDRTECH Corporation
30 Jul 2024K241963WERAYPICOPACK Inc.
5 Jul 2024K241305LifeRay Intraoral Handheld X-ray SystemLucas Lifecare, LLC
13 May 2024K240759REMEX-GR100Remedi Inc.
8 Feb 2024K233914XVbeam2000Shenzhen Xpectvision Technology Co., Ltd.
3 Jan 2024K233395Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)Alliage S/A Industrias Medico Odontologica
28 Dec 2023K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)De Götzen S.R.L.
8 Dec 2023K232085DVAS (DVAS-M, DVAS-W)Genoray Co., Ltd.
28 Nov 2023K232012N1Osstem Implant Co., Ltd.
1 Sep 2023K232068HyperLight Portable X-ray UnitChangzhou Sifary Medical Technology Co., Ltd.
13 Jul 2023K231449Portable X-ray System Model Ray98(P)Ningbo Runyes Medical Instrument Co., Ltd.
6 Jul 2023K223780Lumos 3DX3Dio
3 Mar 2023K221587DHX-70H, XTG-70HDigimed Co., Ltd.
17 Jan 2023K223010Portable X-ray SystemIray Technology Taicang , Ltd.
23 Nov 2022K222569Ai Ray Dental X-Ray DeviceGuilin Woodpecker Medical Instrument Co., Ltd.
26 Oct 2022K223058EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd.
1 Sep 2022K220579Hybrid C70Digimed Co., Ltd.
23 Aug 2022K222274FONA XDCFona S.R.L
29 Jun 2022K221286CLAROXVSI Co., Ltd.
27 Jun 2022K221233DT-703ECOTRON Co., Ltd.
22 Apr 2022K220574HYBRID S70Digimed Co., Ltd.
4 Apr 2022K213282ERI Handheld Dental X-ray System (Model AG100)Energy Resources International Co., Ltd. Hsinchu Branch
28 Jul 2021K211014PortraySurround Medical Systems
28 Dec 2020K201800Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)Nanoray Co., Ltd.
11 Feb 2020K200182EzRay Air Portable (Model: VEX-P300)VATECH Co., Ltd.
27 Dec 2019K192700XcamHdx Will Corp.
19 Dec 2019K190935EZER, Portable X-ray SystemLivermoretech, Inc.
5 Jun 2019K180671MINERht Co., Ltd.
15 Mar 2019K190357Star-X, Intraoral X-ray SystemHdx Will Corp.
13 Sep 2018K182206RiX70 DCTrident SRL
10 Aug 2018K181891Portable X-ray System (Model: MiniX-V, Mini X-S)Digimed Co., Ltd.
4 Apr 2018K180561MobileX Portable X-ray SystemDenterprise International, Inc
16 Mar 2018K172928Portable X-ray SystemRolence Enterprise, Inc.
7 Mar 2018K172810PORT-X IVGenoray Co., Ltd.
16 Nov 2017K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex
8 Jun 2017K170967Intraskan DC PlusSkanray Technologies Limited
24 Jan 2017K163705EzRay Air WVATECH Co., Ltd.
13 Jan 2017K163519RX DCCefla S.C.
1 Sep 2016K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd.
20 Jun 2016K160458BI IMAGE-X EVOLUTIONRadiotecnologia Industrial S.A. DE C.V.
3 Dec 2015K152859Portable X-ray System (Model: MINIX-V / MINIX-S)Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
3 Sep 2014K141293PHOT-X IIS MODEL 505Takara Belmont Corporation
26 Aug 2014K141497PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)Osstem Implant Co., Ltd.
30 May 2014K132378X-MIND UNITYDe Götzen S.R.L.
1 Aug 2013K130109ENDOGRAPH DCVilla Sistemi Medicali S.P.A.
31 Jul 2013K132041REXTAR XMeta Biomed Co, Ltd
16 May 2013K122124PORTABLE X-RAY SYSTEMOsstem Implant Co., Ltd.
1 Mar 2013K122016REXTAR, REXTAR LCDMeta Biomed Co, Ltd
13 Dec 2012K123493VEX-S 100W INTRAORAL X-RAY SYSTEMVATECH Co., Ltd.
7 Dec 2012K122582DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)Denterprise International, Inc
27 May 2011K111330AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAYSkanray Technologies Limited
8 Apr 2011K103600PORTABLE X-RAY SYSTEMDigimed Co., Ltd.
18 Mar 2011K103579INTRA SKAN DCSkanray Technologies Limited
18 Oct 2010K093105VISTEOOwandy
12 May 2010K091255MINXRAY, MODEL: BPD60Minxray, Inc.
22 Mar 2010K093240BELRAY IITakara Belmont Corporation
6 Jan 2010K092772PORTABLE X-RAY SYSTEM, MODEL HAND-RAYHanjin Digi-X Co., Ltd.
9 Oct 2009K092103DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)VATECH Co., Ltd.
29 Jul 2009K091197PLANMECA PROSENSORPlanmeca Oy
18 May 2009K090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191Villa Sistemi Medicali S.P.A.
5 Feb 2009K082875PORTABLE X-RAY SYSTEM, MODEL DXR -1Exaro Co., Ltd.
23 Dec 2008K083344HELIODENT PLUSDentsply Sirona, Inc.
26 Sep 2008K082167PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROXDigimed Co., Ltd.
21 Aug 2008K081899ANYRAY PORTABLE X-RAY SYSTEME-Woo Technology
23 Jun 2008K081664NOMAD PRO X-RAY SYSTEMAribex
14 Mar 2008K080076RX DC X-RAY UNITCefla S.C.R.L.
11 Jan 2007K063121PORTABLE X-RAY SYSTEM, MODEL PORT-X IIGenoray Co., Ltd.
24 Apr 2006K060640DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEMDentamerica
3 Mar 2006K060292KODAK MODELS 2100 AND 2200Kodak-Trophy
14 Jul 2005K051795NOMAD DENTAL X-RAY SYSTEMAribex
24 Jun 2005K051464PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)Planmeca Oy
17 Mar 2005K050255ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4Gendex Dental Systems
24 Feb 2005K043104KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0Practiceworks, Inc.
9 Feb 2005K043612ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200DInstrumentarium Corp. Imaging Division
31 Jan 2005K050019IN EXAM INTRAORAL DENTAL X-RAY SYSTEMKavo America
13 Jan 2005K043557MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMSPanoramic Corp.
6 Jan 2005K043136ELITY 70 X-RAYDental X-Ray E.U.
17 Dec 2004K043307CRANEX DSoredex Palodex Group OY
13 Dec 2004K043092PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015Progeny, Inc.
7 Sep 2004K042260PHOT-X II, MODEL 303Takara Belmont USA, Inc.
13 Jul 2004K040382CRANEX BASEX D OR CRANEX EXCEL DSoredex Palodex Group OY
2 Jun 2004K040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CMTakara Belmont USA, Inc.
29 Apr 2004K033755MINRAYSoredex Palodex Group OY
7 Apr 2004K040556TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORYEastman Kodak Company
20 Feb 2004K033690TROPHYPAN AND TROPHYPAN CTrophy Radiologie
10 Oct 2003K033073ORTHOPHOS XG DS/CEPHDentsply Sirona, Inc.
25 Sep 2003K032355ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WWDentsply Gendex
31 Jul 2003K031448RSV (RADIOLOGY SYSTEM VISIODENTVisiodent SA
21 Jul 2003K031802CORIX 70 PLUS-USVCoramex, S.A.
21 Jul 2003K030634ENDOS DCVilla Sistemi Medicali S.P.A.
8 Jul 2003K031118INTRAOS 70Blue X Imaging Srl
16 Apr 2003K024285A/T X-RAY 70Duerr Dental SE
20 Mar 2003K030647EVA DIGITAL DENTAL X-RAY SYSTEMAfp Imaging Corp.
11 Mar 2003K030185ENDOS AC/ACPVilla Sistemi Medicali S.P.A.
9 Oct 2002K022630MODIFICATION TO FOCUSInstrumentarium Corp.
7 Jun 2002K021378PORTABLE HDX INTRAORAL X-RAYDentalez Group
3 May 2002K021245DEGOTZEN SYNCHROThe Gotzen Group, Inc.
15 Feb 2002K011147CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)Cavitat Medical Technologies, Inc.
4 Feb 2002K013955VERAVIEWEPOCS, MODEL VEJ. Morita USA, Inc.
1 Feb 2002K020070JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002Progeny, Inc.
16 Oct 2001K013176MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWAREAfp Imaging Corp.
9 Aug 2001K012355IMAGE-X SYSTEMTg Group, Inc.
29 Jun 2001K011619PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTATPlanmeca Oy
9 Nov 2000K002062SAMSUNG 10DR IMPLANT SYSTEMSamsung Sds Co., Ltd.
1 Sep 2000K002432STRATO XVilla Sistemi Medicali S.P.A.
13 Jul 2000K001729FOCUSInstrumentarium Corp.
4 May 2000K001248MULTI-PULSE 2000Imaging Sciences Intl., Inc.
3 May 2000K000771DIMAX 2Planmeca Oy
2 May 2000K000672HELIODENT VARIODentsply Sirona, Inc.
28 Apr 2000K000428DIXI 2Planmeca Oy
18 Apr 2000K000163PM 2002 PROLINE/AECPlanmeca Oy
7 Apr 2000K000061MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNITMinxray, Inc.
16 Mar 2000K000551IMAGE X-70 PLUS DENTAL X-RAY UNITMedical Device Consultants, Inc.
14 Mar 2000K994285ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPHDentsply Intl., Inc.
7 Sep 1999K992610GENDEX 765DC, MODEL 110-0154Dentsply Intl., Inc.
25 Jun 1999K991455ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,Trophy Radiologie
22 Jun 1999K991912MODIFICATION TO DIGIPANTrophy Radiologie
18 Jun 1999K991518PANATOMEImaging Sciences Intl., Inc.
18 Jun 1999K991310EXPLOR-X 70Villa Sistemi Medicali S.P.A.
10 Feb 1999K984030VIPERSOFTIntegra Medical
14 Jan 1999K984524AZTECH 70Villa Sistemi Medicali S.P.A.
17 Apr 1998K980581PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEMPlanmeca Oy
14 Apr 1998K980543DENOPTIX BARRIER ENVELOPE (SIZE 0-4)Dentsply Intl., Inc.
27 Mar 1998K974877CRANEX TOME CEPH, OR CRANEX TOMEOrion Corporation Soredex
20 Jan 1998K974077VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.J. Morita USA, Inc.
6 Jan 1998K972921SANKO INTRAORAL DENTAL X-RAYSanko X-Ray Manufacturing Co., Ltd.
21 Nov 1997K973642ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100Instrumentarium Imaging, Inc.
10 Nov 1997K973476KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWEREastman Kodak Company
8 Oct 1997K972968ROTOGRAPH PLUSChicago X-Ray Systems, Inc.
15 Sep 1997K972312SIEMENS ORTHOPHOS DS/DS CEPHSiemens AG
12 Sep 1997K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDPelton & Crane
11 Sep 1997K962422INFIMED DENTAL SYSTEMInfimed, Inc.
5 Sep 1997K972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMPelton & Crane
5 Aug 1997K970812PM 2002 CC PROLINEPlanmeca Oy
14 May 1997K970850SCANRITE DFSScanrite Systems
1 Apr 1997K970975PROSTYLE INTRAPlanmeca Oy
17 Mar 1997K965203RADX SYSTEMElectro Medical Systems SA
26 Feb 1997K970263PM 2002 CC PROLINEPlanmeca Oy
27 Jan 1997K965072PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNITKaycor Intl., Ltd.
2 Jan 1997K963403ACURAY DIGITAL X-RAYNew Image Industries, Inc.
23 Dec 1996K964659ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEMDentsply Intl., Inc.
23 Dec 1996K963699BELRAY/MODEL 096, DENTAL INTRAORAL X-RAYBelmont Equipment Corp.
26 Nov 1996K962631DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEMFair Image, Inc.
2 Oct 1996K963185ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMERElectronic Control Concepts
23 Sep 1996K961826DIGIPANTrophy Radiologie
25 Jul 1996K962337ELITYS OR ELITYS-ETrophy Radiologie
25 Jul 1996K962120TOMOGRAPH ACCESSORIESSteri-Oss, Inc.
11 Dec 1995K955429PROSTYLE INTRAPlanmeca Oy
7 Oct 1995K952763PANORAMIC X-RAY UNIT (MODIFICATION)Planmeca Oy
21 Mar 1994K931300FLASH DENTChicago X-Ray Systems, Inc.
18 Feb 1994K935046GX-770 X-RAY CONTROL, MODEL 46-404600G4Gendex Corp.
25 Jan 1994K932111DENTAL X-RAY UNITCastellini S.P.A.
15 Dec 1993K934063PANORAMIC X-RAY UNITS, MODIFICATIONPlanmeca Oy
29 Sep 1993K925094VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESSGendex Corp.
14 Sep 1993K931001ORALIX DCGendex Corp.
14 Jul 1993K931725ALPHA IIDynarad Corp.
27 Apr 1993K930338ORTHOCEPH OC100Instrumentarium Corp.
30 Mar 1993K926575MAMMOTEST PRODUCT, MODIFICATIONFischer Imaging Corp.
30 Mar 1993K923360PORT-XDMobile Dental Equipment Corp.
27 Nov 1992K924130COFFMAN IMPLANT TOMOGRAPHCoffman Dental
27 Nov 1992K923067SENS-A-RAYRegam Medical Systems
5 Nov 1991K912893ORTHOPANTOMOGRAPH 100Instrumentarium Corp.
30 Oct 1991K913652COFFMAN TOMOGRAPHCoffman Dental
25 Apr 1990K894935S-70 PORTABLE DENTAL X-RAY SYSTEMLorad Medical Systems, Inc.
17 Nov 1989K895467ORTHOPHOS AND ORTHOPHOS CSiemens Medical Solutions USA, Inc.
4 Aug 1988K882436LASER - 1000Panoramic Corp.
17 Jun 1988K875212PXS MODEL PXS7-730EA DENTAL X-RAY SOURCEKevex Corp.
31 Mar 1988K872825AXIAL TOME, 60, FLUORO AND TOMAXAxialtome Corp.
7 Dec 1987K874238MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAYBelmont Equipment Corp.
16 Jul 1987K872240PORTABLE DENTAL X-RAY UNIT MODEL 4000Home/Office Dental, Inc.
4 May 1987K871051FIAD EXPLOR-X; MODEL 70 KVPUnited States Dental
13 Feb 1987K870236PANORAMIC X-RAY MODEL PC-1000Panoramic Corp.
26 Nov 1986K864474DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMICPlanmeca USA, Inc.
1 Jul 1986K860835CEPHALOSTATDallas Dental Co.
6 Mar 1986K854741X-RANGE 65Alpine Dental Equipment Co.
3 Sep 1985K851095INTRAORAL DENTAL X-RAY SYSTEM 70-XTrophy Radiologie
9 Jun 1981K811103GE 900General Electric Co.
3 Mar 1980K800133PANOREX II DENTAL X-RAY UNITPennwalt Corp.
16 Jan 1980K792581GENERAL ELECTRIC PANELIPSE LDGeneral Electric Co.
11 Sep 1978K781288DENTAL X-RAY UNIT HELIODENT 70Siemens AG
11 Sep 1978K781286DENTAL X-RAY UNITSiemens AG
10 Apr 1978K780469PANORAMIC X-RAY, DENTALDen-Tal-Ez Mfg Co., Inc.
2 Dec 1977K772164PANORAMIC X-RAY SYSTEM MODEL ASybron Corp.

Official records: FDA product classification for EHD · 21 CFR 872.1800.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026