Not currently registered with FDA under this name
Trophy Radiologie
Marne La Vallee Cedex 2, France. Named as applicant on 16 dental 510(k) clearances between 1985 and 2004. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 161985–2004
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Trophy Radiologie as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Trophy Radiologie | 16 clearances | 1985–2004 | Below |
| South Korea | MFDS | Manufacturer | TROPHY RADIOLOGIE | 1 | 1999–1999 | 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
510(k) clearances
Clearances on which FDA names Trophy Radiologie as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Feb 2004 | K033690 | TROPHYPAN AND TROPHYPAN C | EHD Extraoral with Timer X-Ray Unit |
| 2 Feb 2004 | K033419 | STV PRO 2 | EIA Operative Dental Unit |
| 3 Jan 2003 | K023346 | TROPHYPAN | MUH Digital Extraoral Source X-Ray System |
| 21 Dec 2001 | K012514 | DIGIPAN / DPI | MUH Digital Extraoral Source X-Ray System |
| 25 Jun 1999 | K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, | EHD Extraoral with Timer X-Ray Unit |
| 22 Jun 1999 | K991912 | MODIFICATION TO DIGIPAN | EHD Extraoral with Timer X-Ray Unit |
| 23 Sep 1996 | K961826 | DIGIPAN | EHD Extraoral with Timer X-Ray Unit |
| 25 Jul 1996 | K962337 | ELITYS OR ELITYS-E | EHD Extraoral with Timer X-Ray Unit |
| 28 Dec 1995 | K953936 | ATLANTIS | EAP Intraoral X-Ray Unit |
| 19 Sep 1995 | K951074 | STOMAVISION (STV) | EIA Operative Dental Unit |
| 30 Jun 1995 | K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | EAP Intraoral X-Ray Unit |
| 19 Apr 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | EAP Intraoral X-Ray Unit |
| 13 Nov 1991 | K913464 | STOMAVISION (STV) | EIA Operative Dental Unit |
| 20 Jul 1989 | K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | EHO Preformed Bar |
| 3 Sep 1985 | K851095 | INTRAORAL DENTAL X-RAY SYSTEM 70-X | EHD Extraoral with Timer X-Ray Unit |
| 31 Jul 1985 | K851136 | TROPHY COMPACT - DENTAL UNIT | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Ray Co., Ltd, (1), Hdx Will Corp. (1), Carestream Dental LLC (1), Osstem Implant Co., Ltd. (1).
Sources
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 of the most recent filing, which can be a US agent.