510(k) K081135 ยท KPS System, Tomography, Computed, Emission
GEMINI CONDOR
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Apr 29, 2008 |
| Received | Apr 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081135
| 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
882476 - Gemini TF Big Bore PET/CT Open, Classified |
KPS | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore CT/PET System.
The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitabl Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jul 10, 2014 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) a Terminated |
KPS | None listed |
| Feb 12, 2014 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH Terminated |
KPS | None listed |
| Feb 4, 2014 | Philips Medical Systems (Cleveland) Inc Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Terminated |
KPS | None listed |
| Feb 26, 2013 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile inst Terminated |
KPS | None listed |
| Aug 22, 2012 | Philips Medical Systems (Cleveland) Inc Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH.
The device is a diagn Terminated |
KPS | None listed |
| Apr 5, 2012 | Philips Medical Systems (Cleveland) Inc GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476, Distributed by: Philips Medical System, Cleveland, OH
Product Usage: The Computed Tomography X-Ray System Terminated |
KPS | None listed |
| Dec 1, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction.
The GEMINI TF I6, and TF 64 Terminated |
KPS | None listed |
| Dec 1, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF 64 Diagnostic CT X-ray/PET Imaging System, Catalog/Model #882471, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction.
The G Terminated |
KPS | None listed |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF Big Bore (BB) Diagnostic Imaging Systems, Model Number: 882476, 510(k) #K081135, Serial Numbers: 9201, 9202, 9203, 9204, 9205, and 9206. The recalled GEMINI TF Big Bore system unit Terminated |
KPS | None listed |
| Aug 1, 2011 | Philips Medical Systems (Cleveland) Inc GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023.
The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combi Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.