510(k) K962738 ยท KPS System, Tomography, Computed, Emission
MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS
| Applicant | GE Medical Systems, Milwaukee WI, US |
| Decision | Substantially Equivalent, Oct 10, 1996 |
| Received | Jul 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962738
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System Terminated |
KPS | None listed |
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System Terminated |
KPS | None listed |
| Nov 14, 2018 | GE Healthcare, LLC GE Healthcare Millennium MC Terminated |
KPS | None listed |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging system. It is comprised of 2 digital CSE (Correlated Signal Enhancement) detectors in varia Terminated |
KPS | None listed |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and Terminated |
KPS | None listed |
| Jan 24, 2006 | GE Healthcare GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a multi-purpose single-head nuclear medicine imaging system, comprised of a Digital CSE (Correlated Signal Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.