510(k) · Cleared
Recalled · 2006Gemini 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 Nov 9, 2004 as substantially equivalent to K041955 (Philips Medical Systems (Cleveland), Inc., 2004) after a 15-day review. Its family tree reaches back 6 generations to 1993. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 9, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930090 (1993). 18 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- 1 generation backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- This deviceK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004
- Descendant · cites it directly · 13 of its ownK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- Descendant · 2 generations on · 12 of its ownK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
- Descendant · 3 generations on · 4 of its ownK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
- Descendant · 4 generations on · 2 of its ownK210880 Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021
- Descendant · 3 generations on · 2 of its ownK140651 Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · cites it directly13descendants
- K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · 2 generations on12descendants
- K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · 3 generations on4descendants
- K210880Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021 · 4 generations on2descendants
- K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| −1 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| 0 (this device) | K042935 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2004 | — |
| +1 | K051170 | Gemini GXL | Philips Medical Systems (Cleveland), Inc. | 2005 | 12 |
| +2 | K052640 | Gemini Raptor | Philips Medical Systems (Cleveland), Inc. | 2005 | 36 |
| +3 | K123599 | Ingenuity Digital Pet/CT | Philips Healthcare (Cleveland) | 2013 | 5 |
| +4 | K210880 | Vereos PET/CT | Philips Medical Systems Nederland B.V. | 2021 | — |
| +3 | K140651 | Celesteion, Pca-9000A/2 | Toshibamedical Systems Corporation | 2014 | 2 |
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 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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 18.7 · 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 |
|---|---|---|---|
| * | K041955 | Gemini Pet/CT Imaging SystemSummary page 1…ode: 90 KPS and 90 JAK ClassificationPanel: Radiology C. Dateprepared: October 8, 2004 D. PredicateDevice: Gemini System (K041955) E. PerformanceStandards: * 21 CFR 1020.30 - 1020.33 Performance Standards for Ionizing Radiation Emitting… | 2004 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051170 | Gemini GXL | 2005 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2006 | Not classified | Z-0013-2007 | Other | A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator. |
| Aug 18, 2005 | Not classified | Z-0068-06 | Other | The image balance center point correction algorithm used in CT image reconstruction may cause a disapperance or alteration of small circular anatomical structures that are both near the image center and perpendicular to the image plane.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 18 ancestors have a recall of any class.
- Of its descendants, K051170 (Philips Medical Systems (Cleveland), Inc., 2005) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K041955.
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 (262 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 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.
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/K042935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042935: Gemini GXL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042935
Report an extraction error
Are you the manufacturer?
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