510(k) K161574 ยท KPS System, Tomography, Computed, Emission
Discovery MI
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 11, 2016 |
| Received | Jun 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161574
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2019 | GE Healthcare, LLC Discovery Ml
Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatom Open, Classified |
KPS | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring Terminated |
KPS | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery Ml X-ray system Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.