510(k) K141477 ยท KPS System, Tomography, Computed, Emission
DISCOVERY IQ
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 18, 2014 |
| Received | Jun 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2019 | GE Healthcare, LLC Discovery IQ
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 anatomy Open, Classified |
KPS | None listed |
| May 24, 2018 | GE Healthcare, LLC Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22 Terminated |
KPS | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Discovery IQ 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.