GEMINI GXL— 510(k) K051170
Substantially EquivalentPhilips Medical Systems (Cleveland), Inc.
FDA 510(k) clearance K051170 for GEMINI GXL, Substantially Equivalent on 2005-05-23. Applicant: Philips Medical Systems (Cleveland), Inc.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code KPS
view allMore clearances from Philips Medical Systems (Cleveland), Inc.
view allRecalls naming K051170
K-number listed on FDA's recall record- Z-0278-2022 — 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 radiologists to produce real-time CT images to facilitate image-guided surgery.
- Z-0280-2022 — 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 to produce real-time CT images to facilitate image-guided surgery.
- Z-2193-2015 — 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 suitable for a wide range of diagnostic applications.
- Z-1781-2015 — Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
- Z-2239-2012 — 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 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 cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: " The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. " The detection, localization, and staging of tumors and diagnosing cancer patients. " Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.
- Z-0197-2016 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051170.
Data sourced from openFDA. This site is unofficial and independent of the FDA.