# K051170: Gemini GXL

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: May 23, 2005 after 17 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930090 (1993). 20 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042935: Gemini GXL, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 1.
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K052640: Gemini Raptor (2005), 12 descendants of its own
- K123599: Ingenuity Digital Pet/CT (2013), 4 descendants of its own
- K210880: Vereos PET/CT (2021), 2 descendants of its own
- K140651: Celesteion, Pca-9000A/2 (2014), 2 descendants of its own
- K170490: Celesteion, PCA-9000A/3 (2017), 1 descendant of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-0280-2022: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, b
- May 1, 2021 · Class II · Z-0278-2022: Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, b
- Jul 1, 2015 · Class II · Z-2193-2015: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
- Mar 6, 2015 · Class II · Z-1781-2015: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overh
- Aug 8, 2012 · Class II · Z-2239-2012: Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the
- Jan 26, 2012 · Not classified · Z-1368-2012: TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving 
- Feb 19, 2009 · Not classified · Z-1579-2009: A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units.
- Jan 26, 2009 · Not classified · Z-0260-2010: Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required, which may reduce the product's load bearing capacity, resulting in cracking under les
- Nov 24, 2008 · Not classified · Z-0286-2010: A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.
- May 1, 2008 · Class II · Z-0197-2016: The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT subsystem of potentially affected GEMINI PET/CT systems are susceptible to premature failure.
- Sep 21, 2007 · Not classified · Z-0462-2008: Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.
- Sep 21, 2007 · Not classified · Z-0461-2008: Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.

## Indications for use
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, head, 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 nray 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. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium, Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

Source page: https://510kreport.com/device/K051170
Methodology: https://510kreport.com/methodology