510(k) K242005 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Versana Premier; Versana Premier Lotus; LOGIQ F
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US |
| Decision | Substantially Equivalent, Oct 2, 2024 |
| Received | Jul 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system Open, Classified |
IYN | None listed |
| Jun 26, 2025 | GE Medical Systems China Co., Ltd. GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers:
1) Versana Premier R3 VS, Model/Catalog Number 5938558;
2) Versana Premier R3 VA, Model/Catalog N Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.