Trophy Radiologie: FDA clearances and approvals
Trophy Radiologie has 16 FDA 510(k) clearances (first 1985, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time: 114 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 6 | 6 |
| EIA | Unit, Operative Dental | 4 | 4 |
| EAP | Unit, X-Ray, Intraoral | 3 | 3 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| EHO | Bar, Preformed | 1 | 1 |
Review panels
Most recent Trophy Radiologie 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033690 | TROPHYPAN AND TROPHYPAN C | EHD | 2004-02-20 | 88 |
| K033419 | STV PRO 2 | EIA | 2004-02-02 | 98 |
| K023346 | TROPHYPAN | MUH | 2003-01-03 | 88 |
| K012514 | DIGIPAN / DPI | MUH | 2001-12-21 | 137 |
| K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, | EHD | 1999-06-25 | 60 |
| K991912 | MODIFICATION TO DIGIPAN | EHD | 1999-06-22 | 15 |
| K961826 | DIGIPAN | EHD | 1996-09-23 | 133 |
| K962337 | ELITYS OR ELITYS-E | EHD | 1996-07-25 | 38 |
| K953936 | ATLANTIS | EAP | 1995-12-28 | 129 |
| K951074 | STOMAVISION (STV) | EIA | 1995-09-19 | 194 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Trophy Radiologie.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Trophy Radiologie have?
Trophy Radiologie has 16 FDA 510(k) clearances (first 1985, latest 2004), across 5 product codes in 2 review panels.
How long does FDA take to clear Trophy Radiologie's 510(k)s?
The median time from FDA receipt to decision across Trophy Radiologie's cleared 510(k)s is 114 days.
What devices does Trophy Radiologie make?
Its most frequent FDA product codes are EHD (Unit, X-Ray, Extraoral With Timer, 6); EIA (Unit, Operative Dental, 4); EAP (Unit, X-Ray, Intraoral, 3).
Has Trophy Radiologie had device recalls?
openFDA lists no recalls under a recalling firm name matching Trophy Radiologie. Related entities may recall under other names.
Next steps
- See all 16 Trophy Radiologie clearances with predicates and recalls
- Run predicate analysis for product code EHD, Trophy Radiologie's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.