FDA applicant
Shimadzu Medical Systems
FDA records 91 decisions for Shimadzu Medical Systems (Gardena, CA) from 1989 to 2021: 91 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Its devices cite 15 predicates, 11 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Shimadzu Corporation Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shimadzu Medical Systems’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Shimadzu Medical Systems’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.