510(k) · Cleared
Recalled · Class II · 2021Gemini GXL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission
Cleared on May 23, 2005 as substantially equivalent to K042935 (Philips Medical Systems (Cleveland), Inc., 2004) and 1 other predicate after a 17-day review. Its family tree reaches back 7 generations to 1993. 13 later devices descend from it. It has been recalled 12 times.
- Decided
- May 23, 2005
- Review
- 17 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930090 (1993). 20 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK930090 HelicatElscint, Inc. · 1993
- 6 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 5 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 4 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 2 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 1 generation backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- This deviceK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005
- Descendant · cites it directly · 12 of its ownK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- Descendant · 2 generations on · 4 of its ownK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
- Descendant · 3 generations on · 2 of its ownK210880 Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021
- Descendant · 2 generations on · 2 of its ownK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK170490 Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · cites it directly12descendants
- K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · 2 generations on4descendants
- K210880Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021 · 3 generations on2descendants
- K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · 2 generations on2descendants
- K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −6 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −5 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −4 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −3 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −2 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −1 | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| 0 (this device) | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | — |
| +1 | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | 36 |
| +2 | K123599 | Ingenuity Digital Pet/CT | Philips Healthcare (Cleveland) | 2013 | 5 |
| +3 | K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | — |
| +2 | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | 2 |
| +3 | K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042935 | Gemini GXLSummary page 1…Code: 90 KPS and 90 JAK Classification Panel: Radiology C. Date prepared: April 8, 2005 D. Predicate Device: Gemini System (K042935) "Philips Plus" CT Scanner (K033326) E_ Performance Standards: * 21 CER 1020.30 - 1020.33… | 2004 |
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 1…iology C. Date prepared: April 8, 2005 D. Predicate Device: Gemini System (K042935) "Philips Plus" CT Scanner (K033326) E_ Performance Standards: * 21 CER 1020.30 - 1020.33 Performance Standards for Ionizing Radiation Emitting P… | 2003 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052640 | Gemini Raptor | 2005 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2021 | Class II | Z-0280-2022 | Device Design | 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, bystander, or service person located in… |
| May 1, 2021 | Class II | Z-0278-2022 | Device Design | 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, bystander, or service person located in… |
| Jul 1, 2015 | Class II | Z-2193-2015 | Software design | 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 | Nonconforming Material/Component | 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, overheating and/or emission of fumes. |
| Aug 8, 2012 | Class II | Z-2239-2012 | Material/Component Contamination | 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 batteries, housed within the UPS… |
| Jan 26, 2012 | Not classified | Z-1368-2012 | Software design (manufacturing process) | 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 while a contour is in edit mode, that… |
| Feb 19, 2009 | Not classified | Z-1579-2009 | Software design | 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. The software defect results in a the… |
| Jan 26, 2009 | Not classified | Z-0260-2010 | Process change control | 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 less than the designed full-load weight. |
| Nov 24, 2008 | Not classified | Z-0286-2010 | Process design | 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 | Unknown/Undetermined by firm | 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 | Software design | 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 | Software design | 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. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K052640 (Philips Medical Systems (Cleveland), Inc., 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
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…
Read the full statement (259 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051170: Gemini GXL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051170
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026