510(k) K133657 ยท KPS System, Tomography, Computed, Emission
DISCOVERY PET/CT 710
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Mar 21, 2014 |
| Received | Nov 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2019 | GE Healthcare, LLC Discovery PET/CT 710
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 Open, Classified |
KPS | None listed |
| Jun 19, 2019 | GE Healthcare, LLC Discovery Ml DR
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 anat Open, Classified |
KPS | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery MI Digital Ready Terminated |
KPS | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery Ml DR 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.