510(k) · Cleared
Recalled · Class II · 2021Gemini Condor
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 Apr 29, 2008 as substantially equivalent to K052640 (Philips Medical Systems (Cleveland), Inc., 2005) and 1 other predicate after an 8-day review. Its family tree reaches back 9 generations to 1993. It has been recalled 13 times.
- Decided
- Apr 29, 2008
- Review
- 8 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930090 (1993). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations between
- 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- This deviceK081135 Gemini CondorPhilips Medical Systems (Cleveland), Inc. · 2008
Show all 9 generations
- Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 4 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- This deviceK081135 Gemini CondorPhilips Medical Systems (Cleveland), Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −8 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −7 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −6 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −5 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −4 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −3 | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| −2 | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | 12 |
| −1 | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | 36 |
| 0 (this device) | K081135 | Gemini Condor | Philips Medical Systems (Cleveland), Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K052640 | Gemini RaptorSummary page 1…and 90 JAK Classification Panel: Radiology C. Date prepared: March 17, 2008 D. Predicate Device: GEMINI Raptor System (K052640) (GEMINI TF) AcQSim Multislice CT Scanner (K033357)… | 2005 |
| * | K033357 | Acqsim-Multislice-CT, Model 453567042271Summary page 1…ice: GEMINI Raptor System (K052640) (GEMINI TF) AcQSim Multislice CT Scanner (K033357) (Brilliance CT Big Bore) E. Performance Standards: * 21 CFR 1020.30 - 1020.33 Performance S… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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-1989-2021 | 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… |
| Jul 1, 2015 | Class II | Z-2199-2015 | 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-1789-2015 | 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 5, 2013 | Class II | Z-0979-2014 | Software design | The TF Big Bore patient table experienced mechanical binding during horizontal table motion resulting in an automatic Emergency Stop (E-stop). An E-Stop will interrupt a current scan, resulting in an incomplete study. |
| 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. |
| Oct 24, 2012 | Class II | Z-0883-2013 | 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… |
| May 31, 2011 | Not classified | Z-3201-2011 | 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… |
| Apr 25, 2011 | Not classified | Z-0343-2012 | Software design | In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in… |
| Apr 25, 2011 | Not classified | Z-0344-2012 | Software design | In response to complaints received by Philips Medical concerning certain identified software errors reported by their customers, the firm is conducting a recall/software correction to several of their GEMINI PET/CT X-ray system units in… |
| Aug 5, 2009 | Not classified | Z-2915-2011 | Software design (manufacturing process) | Two non-safety related defects have been found on the Philips GEMINI TF Big Bore running version 3.6; if these defects were to recur, it could impact the performance or reliability of the system. Philips is issuing a software update to… |
The 5 latest of 13 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 15 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 15 of the 24 ancestors have a recall of any class.
- 5 other devices also cite its predicate K052640.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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/K081135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081135: Gemini Condor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081135
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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