Registered with FDA
Owandy Radiology SAS
CROISSY-BEAUBOURG, France. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1059 registrations outside the US
- Establishments
- 1France
Registered in 10 markets
Where regulators' registries name Owandy Radiology SAS as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Owandy Radiology SAS | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | OWANDY RADIOLOGY | 27 | 2014–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Owandy Radiology | 9 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Owandy RadiologyOWANDY RADIOLOGY | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OWANDY RADIOLOGY | 5 | 2020–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OWANDY RADIOLOGY | 3 | 2023–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Owandy Radiology SAS | 2 | 2019–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | OWANDY Radiology | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Owandy Radiology S.a.s | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OWANDY RADIOLOGY | 1 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Owandy Radiology SAS currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | I-MAXI-MAX 3DI-MAX TouchI-MAX Touch 3DNPR1000AAONEOpteoOwandy-CR | 2014 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | I-MAX TouchOw-RXOwandy-RX DCOwandy-RX PRO | 2014 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Lister | I-MAX 3D | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Owandy Radiology SAS lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: De Götzen S.R.L. (4), Villa Sistemi Medicali S.P.A. (3), Nical Spa (1), Owandy (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Dec 2023 | K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | EHD Extraoral with Timer X-Ray Unit |
| 5 Feb 2021 | K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | De Götzen S.R.L. | MUH Digital Extraoral Source X-Ray System |
| 18 Nov 2020 | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | De Götzen S.R.L. | OAS Dental Computed Tomography X-Ray |
| 18 Mar 2015 | K143703 | NICAL SMART MICRO CR system for intraoral dental images | Nical Spa | MUH Digital Extraoral Source X-Ray System |
| 30 May 2014 | K132378 | X-MIND UNITY | De Götzen S.R.L. | EHD Extraoral with Timer X-Ray Unit |
| 28 Apr 2014 | K133271 | OPTEO, VIDEOGRAPH HD | Owandy | MUH Digital Extraoral Source X-Ray System |
| 1 Aug 2013 | K130109 | ENDOGRAPH DC | Villa Sistemi Medicali S.P.A. | EHD Extraoral with Timer X-Ray Unit |
| 22 Jul 2011 | K111152 | ROTOGRAPH EVO 3D | Villa Sistemi Medicali S.P.A. | MUH Digital Extraoral Source X-Ray System |
| 18 May 2009 | K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | Villa Sistemi Medicali S.P.A. | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OWANDY RADIOLOGYFDA reg. 9615832 | CROISSY-BEAUBOURG Seine-et-Marne, France | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9042115). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.