FDA applicant
Toshiba America Medical Systems, In.C
FDA records 146 decisions for Toshiba America Medical Systems, In.C (Tustin, CA) from 1989 to 2014: 146 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 167 predicates, 92 of them its own earlier devices. 78 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Toshiba America Medical Systems, In.C’s devices, and how often a recall has named them.
FDA decisions per year
3in 2014
2026 so far, outlined.
Recalls per year
2in 2024
Class I Class II/III not classified
Planning a device like Toshiba America Medical Systems, In.C’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 “Toshiba”
FDA records each applicant name separately; these may or may not be the same firm.