510(k) K082374 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
VIVID I AND VIVID Q
| Applicant | Ge Medical Systems Israel, Ultrasound, Ltd., Tirat Carmel, IL |
| Decision | Substantially Equivalent, Sep 2, 2008 |
| Received | Aug 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082374
| 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 |
| Dec 22, 2022 | GE Medical Systems, LLC Vivid q ultrasound.
Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult a Open, Classified |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.