510(k) K123599 ยท KPS System, Tomography, Computed, Emission
INGENUITY DIGITAL PET/CT
| Applicant | Philips Healthcare (Cleveland), Cleveland OH, US |
| Decision | Substantially Equivalent, Jul 12, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882446 - Vereos PET/CT Open, Classified |
KPS | None listed |
| Aug 6, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT
Model # 882446, computed tomography x-ray system Terminated |
JAK | None listed |
| Jun 3, 2019 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Model No. 882446
Product Usage:
Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruct Terminated |
KPS | None listed |
| Sep 4, 2018 | Philips Medical Systems (Cleveland) Inc Vereos PET/CT, Software version 2.0.1.
Model Number: 882446
Product Usage:
The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Terminated |
KPS | None listed |
| May 21, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Digital PET/CT System, Model 882446 with the following UDI's:
(01)00884838059559(21)900004
(01)00884838059559(21)900005
(01)00884838059559(21)900006
(01)00884838059559(21)900007
(01)0088483 Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.