510(k) K253597 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
| Applicant | Canon Medical Systems Corporation, Otawara-Shi, JP |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253597
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.