FDA applicant
Shimadzu Corp.
FDA records 58 decisions for Shimadzu Corp. (Torrance, CA) from 1979 to 2026: 58 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 10 of them its own earlier devices. 36 recalls are linked to its devices.
FDA’s records also spell it “Shimadzu Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shimadzu Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
2in 2026
Class I Class II/III not classified
Planning a device like Shimadzu Corp.’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 “Shimadzu”
FDA records each applicant name separately; these may or may not be the same firm.