FDA applicant
Fujifilm Medical Systems U.S.A, Inc.
FDA records 40 decisions for Fujifilm Medical Systems U.S.A, Inc. (Stamford, CT) from 2005 to 2018: 39 510(k) clearances and 1 original PMA approval. Most are in product codes LLZ (System, Image Processing, Radiological) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 57 predicates, 14 of them its own earlier devices. 18 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fujifilm Medical Systems U.S.A, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Fujifilm Medical 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) ReportOther applicant names beginning “Fujifilm”
FDA records each applicant name separately; these may or may not be the same firm.