FDA applicant
Fujifilm Medical System U.S.A., Inc.
FDA records 72 decisions for Fujifilm Medical System U.S.A., Inc. (Stamford, CT) from 1988 to 2017: 71 510(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…). Its devices cite 59 predicates, 20 of them its own earlier devices. 9 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 System U.S.A., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
3in 2017
Class I Class II/III not classified
Planning a device like Fujifilm Medical System 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.