510(k) Report

FDA applicant

Trophy

Croissy-Beaubourg, FR15 decisions2008–20203 recalls

FDA records 15 decisions for Trophy (Croissy-Beaubourg, FR) from 2008 to 2020: 15 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 109 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Trophy’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2008: 32010: 12011: 12012: 22014: 22015: 22018: 22020: 2
2008high 3 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015: 22021: 1
2008high 2 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Trophy by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Trophy”

FDA records each applicant name separately; these may or may not be the same firm.