510(k) K243132 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6)
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd., Shantou, CN |
| Decision | Substantially Equivalent, Dec 10, 2024 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243132
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.