510(k) K052640 ยท KPS System, Tomography, Computed, Emission
GEMINI RAPTOR
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 7, 2005 |
| Received | Sep 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052640
| 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
882442/882456 - Ingenuity TF PET/CT Open, Classified |
JAK | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT
System Number: 882438
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and ra Open, Classified |
KPS | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64
System Number: 882471
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to Open, Classified |
KPS | None listed |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT 882442 Terminated |
KPS | None listed |
| Feb 15, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT, Model No. 882442
Product Usage:
The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of d Terminated |
KPS | None listed |
| Nov 1, 2017 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system Terminated |
KPS | None listed |
| Nov 2, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Terminated |
JAK | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI LXL 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 suitable for a Terminated |
KPS | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF 16 Slice 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 |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF 64 Slice 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 |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Ready 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 suitable f Terminated |
KPS | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Base 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 suitable fo Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc GEMINI TF Ready (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 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 |
| Oct 25, 2013 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT
Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces Terminated |
KPS | None listed |
| Apr 1, 2013 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT.
Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Terminated |
KPS | None listed |
| Feb 28, 2013 | Philips Medical Systems (Cleveland) Inc Ingenuity TF PET/CT. Diagnostic imaging system Terminated |
KPS | None listed |
| Feb 26, 2013 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) 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 |
| Feb 17, 2012 | Philips Medical Systems (Cleveland) Inc TruFlight Select PET/CT System equipped with software version 3.5.3.10, Model #459800111661.
A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography ( Terminated |
KPS | None listed |
| Feb 2, 2012 | Philips Medical Systems (Cleveland) Inc GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH
The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emis Terminated |
KPS | None listed |
| Jan 18, 2012 | Philips Medical Systems (Cleveland) Inc GEMINI TF 16 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model # 882470 & GEMINI TF 64 PET/CT System (with software version 3.5.1 and 3.5.1.1), Model #882471 Philips Medical Systems, Hig Terminated |
KPS | None listed |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped wi Terminated |
JAK | None listed |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with so Terminated |
JAK | None listed |
| Nov 17, 2009 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Sl Terminated |
JAK | None listed |
| Nov 13, 2009 | Philips Medical Systems (Cleveland) Inc GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640 Terminated |
JAK | None listed |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2 Terminated |
KPS | None listed |
| Jan 31, 2008 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomog Terminated |
KPS | None listed |
| Jan 31, 2008 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.