510(k) K051170 ยท KPS System, Tomography, Computed, Emission
GEMINI GXL
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, May 23, 2005 |
| Received | May 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051170
| 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 - Gemini GXL 16 Slice
System Number: 882410
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiol Open, Classified |
KPS | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16
System Number: 882470
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists Open, Classified |
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 GXL 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 suitab Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. 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 GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410, Distributed by: Philips Medical System, Cleveland, OH
Product Usage: The Computed Tomography X-Ray Systems are Terminated |
KPS | None listed |
| Nov 17, 2009 | Philips Medical Systems (Cleveland) Inc Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems Terminated |
JAK | None listed |
| Nov 13, 2009 | Philips Medical Systems (Cleveland) Inc GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170. Terminated |
JAK | None listed |
| Jul 6, 2009 | Philips Medical Systems (Cleveland) Inc TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as 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.