510(k) K172406 ยท KPS System, Tomography, Computed, Emission
Ingenuity TF
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 6, 2017 |
| Received | Aug 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT
Model # 882456, computed tomography x-ray system Terminated |
JAK | None listed |
| Dec 19, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT (non-RoHS), Model Number 882456
This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subs Terminated |
KPS | None listed |
| Dec 11, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT (model 882442) running software version 4.0.2
This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) syste Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.