510(k) K212960 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Mar 22, 2022 |
| Received | Sep 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2022 | Canon Medical System, USA, INC. Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450 Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.