FDA applicant
Toshibamedical Systems Corporation
FDA records 80 decisions for Toshibamedical Systems Corporation (Otawara-Shi, JP) from 2004 to 2018: 80 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 104 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 126 predicates, 62 of them its own earlier devices. 49 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Toshibamedical Systems Corporation’s devices, and how often a recall has named them.
FDA decisions per year
5in 2018
2026 so far, outlined.
Recalls per year
2in 2021
Class I Class II/III not classified
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