FDA applicant
Fujifilm Healthcare Corporation
FDA records 6 decisions for Fujifilm Healthcare Corporation (Kashiwa-Shi, JP) from 2022 to 2024: 6 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fujifilm Healthcare Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Fujifilm Healthcare Corporation’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.