510(k) K061525 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE VIVID - I
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 3, 2006 |
| Received | Jun 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2022 | GE Medical Systems, LLC Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pe Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.