Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trophy Radiologie · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
194 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033690 | TROPHYPAN AND TROPHYPAN C | Trophy Radiologie | 2004-02-20 | 88 | 0 |
| K033419 | STV PRO 2 | Trophy Radiologie | 2004-02-02 | 98 | 0 |
| K023346 | TROPHYPAN | Trophy Radiologie | 2003-01-03 | 88 | 0 |
| K012514 | DIGIPAN / DPI | Trophy Radiologie | 2001-12-21 | 137 | 0 |
| K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS10 | Trophy Radiologie | 1999-06-25 | 60 | 0 |
| K991912 | MODIFICATION TO DIGIPAN | Trophy Radiologie | 1999-06-22 | 15 | 0 |
| K961826 | DIGIPAN | Trophy Radiologie | 1996-09-23 | 133 | 0 |
| K962337 | ELITYS OR ELITYS-E | Trophy Radiologie | 1996-07-25 | 38 | 0 |
| K953936 | ATLANTIS | Trophy Radiologie | 1995-12-28 | 129 | 0 |
| K951074 | STOMAVISION (STV) | Trophy Radiologie | 1995-09-19 | 194 | 0 |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | 1995-06-30 | 147 | 0 |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | 1995-04-19 | 71 | 0 |
| K913464 | STOMAVISION (STV) | Trophy Radiologie | 1991-11-13 | 100 | 0 |
| K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | Trophy Radiologie | 1989-07-20 | 491 | 0 |
| K851095 | INTRAORAL DENTAL X-RAY SYSTEM 70-X | Trophy Radiologie | 1985-09-03 | 168 | 0 |
| K851136 | TROPHY COMPACT - DENTAL UNIT | Trophy Radiologie | 1985-07-31 | 132 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda