510(k) · Cleared
Recalled · Class II · 2021Gemini Raptor
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 Oct 7, 2005 as substantially equivalent to K051170 (Philips Medical Systems (Cleveland), Inc., 2005) after an 11-day review. Its family tree reaches back 8 generations to 1993. 12 later devices descend from it. It has been recalled 36 times.
- Decided
- Oct 7, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 36
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930090 (1993). 21 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK930090 HelicatElscint, Inc. · 1993
- 7 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 6 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 5 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 3 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 2 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 1 generation backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- This deviceK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005
- Descendant · cites it directly · 4 of its ownK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK210880 Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021
- Descendant · cites it directly · 2 of its ownK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK170490 Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK251401 PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania · 2025
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · cites it directly4descendants
- K210880Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021 · 2 generations on2descendants
- K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · cites it directly2descendants
- K170490Celesteion, PCA-9000A/3Toshibamedical Systems Corporation · 2017 · 2 generations on1descendant
- K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −7 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −6 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −5 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −4 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −3 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −2 | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −1 | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | 12 |
| 0 (this device) | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | — |
| +1 | K123599 | Ingenuity Digital Pet/CT | Philips Healthcare (Cleveland) | 2013 | 5 |
| +2 | K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | — |
| +1 | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | 2 |
| +2 | K170490 | Celesteion, PCA-9000A/3 | Toshibamedical Systems Corporation | 2017 | — |
| +2 | K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K051170 | Gemini GXL | 2005 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-0279-2022 | 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-0281-2022 | 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-1987-2021 | Device Design | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining… |
| Mar 28, 2018 | Class II | Z-2276-2018 | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. |
| Feb 15, 2018 | Class II | Z-1392-2018 | Under Investigation by firm | Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding. |
| Nov 1, 2017 | Class II | Z-0522-2018 | Vendor change control | One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware. |
| Jul 1, 2015 | Class II | Z-2194-2015 | 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. |
| Jul 1, 2015 | Class II | Z-2196-2015 | 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. |
| Jul 1, 2015 | Class II | Z-2197-2015 | 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. |
| Jul 1, 2015 | Class II | Z-2195-2015 | 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. |
| Jul 1, 2015 | Class II | Z-2198-2015 | 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-1787-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1785-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1783-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1788-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1782-2015 | 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. |
| Mar 6, 2015 | Class II | Z-1786-2015 | 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. |
| Jun 18, 2014 | Class II | Z-2037-2014 | Software design | When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to the operator, but disappears before action can be taken. If this occurs it results in an inability to close E-Stop and the system is not… |
| Dec 4, 2013 | Class II | Z-0932-2014 | Software design | The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisition is complete and will not allow the PET acquisition to begin, resulting in an unexpected incomplete study. |
| Aug 16, 2013 | Class II | Z-0067-2014 | Software design | Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. |
| Jan 21, 2013 | Class II | Z-0897-2013 | Software design | The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients. |
| Dec 20, 2012 | Class II | Z-1029-2013 | Software design | Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605.0 that if they were to re-occur, could cause a risk for patients, users or service personnel, including inaccurate standard uptake values… |
| Oct 24, 2012 | Class II | Z-0882-2013 | Software design | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/CT X-Ray scanning systems has the capability to generate Intensity Projection data sets from respiratory gated data. A circumstance was… |
| 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-1369-2012 | 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… |
| Dec 13, 2011 | Not classified | Z-1056-2012 | Software design | A number of non-conformances have been noted in the TruFlight Select PET/CT System. A number of these non-conformances have been corrected to improve the overall quality and functionality of the suspect system units. |
| Dec 2, 2011 | Not classified | Z-0805-2012 | Software design | Philips received notification by a customer of an issue relating to unwanted auto delete occurrences resulting in raw data being deleted and, in some cases, raw data being deleted immediately after scan acquisition but before images are… |
| Oct 24, 2011 | Not classified | Z-0937-2012 | Material/Component Contamination | Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor. |
| May 31, 2011 | Not classified | Z-3200-2011 | Software design | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the… |
| May 31, 2011 | Not classified | Z-3199-2011 | Software design | The firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in the field. The firm believes that if these software defects were to recur, it could impact the performance of reliability of the… |
| Feb 19, 2009 | Not classified | Z-1580-2009 | 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-0261-2010 | 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-0287-2010 | 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 36 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.
- 12 of the 21 ancestors have a recall of any class.
- Of its descendants, K123599 (Philips Healthcare (Cleveland), 2013) has gone furthest, with 4 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, brain, heart…
Read the full statement (278 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, 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:
o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
o The detection, localization, and staging of tumors and diagnosing cancer patients.
o Treatment planning and interventional radiology procedures.
The device includes software that provides a quantified analysis of regional cerebral activity from PET images.
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/K052640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052640: Gemini Raptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052640
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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