FDA applicant
Hitachi Medical Systems America, Inc.
FDA records 100 decisions for Hitachi Medical Systems America, Inc. (Twinsburg, OH) from 1991 to 2017: 100 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and MOS (Coil, Magnetic Resonance, Specialty). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 60 predicates, 43 of them its own earlier devices. 38 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hitachi Medical Systems America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Hitachi Medical Systems America, 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 “Hitachi”
FDA records each applicant name separately; these may or may not be the same firm.