FDA applicant

Fujifilm Meidcal Systems U.S.A.,Inc.

Stamford, CT2 decisions2014–20140 recalls

FDA records 2 decisions for Fujifilm Meidcal Systems U.S.A.,Inc. (Stamford, CT) in 2014: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is 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 Fujifilm Meidcal Systems U.S.A.,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Fujifilm Meidcal Systems U.S.A.,Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fujifilm Meidcal Systems U.S.A.,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Fujifilm”

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

Fujifilm Medical System U.S.A., Inc. 72 Fujifilm Corporation 71 Fujifilm Medical Systems U.S.A, Inc. 40 FUJIFILM Sonosite, Inc. 25 FUJIFILM Healthcare Americas Corporation 13 Fujifilm Healthcare Corporation 6 Fujifilm Corporaton 6 Fujifilm Irvine Scientific 5 Fujifilm New Development U.S.A., Inc. 3 Fujifilm Medwork GmbH 2

Fujifilm Meidcal Systems U.S.A.,Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fujifilm”