510(k) K243298 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
| Applicant | Carbon (Shenzhen) Medical Device Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 3, 2025 |
| Received | Oct 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243298
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.