510(k) K051855 ยท KPS System, Tomography, Computed, Emission
VENTRI
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Aug 2, 2005 |
| Received | Jul 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051855
| 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 |
| Sep 17, 2009 | GE Medical Systems, LLC GE Healthcare Ventri, GE Healthcare, Waukesha, WI.
Model number(s): H3000YW, H3000YY, H3000ZW, H3000YT.
The intended use of the VENTRi system is to perform nuclear imaging procedures for detection an Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.