510(k) K080124 ยท KPS System, Tomography, Computed, Emission
VENTRI 1.1
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jan 31, 2008 |
| Received | Jan 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080124
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2020 | GE Healthcare, LLC System, Tomography Computed Emmission Open, Classified |
KPS | None listed |
| Apr 24, 2013 | GE Healthcare, LLC Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.