510(k) · Cleared
Recalled · Class II · 2019Ingenuity TF
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 6, 2017 as substantially equivalent to K052640 (Philips Medical Systems (Cleveland), Inc., 2005) after a 58-day review. Its family tree reaches back 9 generations to 1993. It has been recalled 3 times.
- Decided
- Oct 6, 2017
- Review
- 58 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K930090 (1993). 22 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 deviceK172406 Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 2017
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 deviceK172406 Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 2017
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) | K172406 | Ingenuity TF | Philips Medical Systems (Cleveland), Inc. | 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 |
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 |
|---|---|---|---|
| * | K052640 | Gemini RaptorSummary page 6…Trade Name: Ingenuity TF Device: Manufacturer: Philips Medical Systems (Cleveland), Inc. 510(k) Clearance: K052640 (October 7, 2005, under name Gemini Raptor) Classification Na… | 2005 |
| † | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | 2016 |
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 |
|---|---|---|---|---|
| Jun 24, 2019 | Class II | Z-2193-2019 | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied |
| Dec 19, 2018 | Class II | Z-0823-2019 | Software design | A software update is being issued to correct multiple issues identified in the previous software version. |
| Dec 11, 2017 | Class II | Z-0562-2018 | Software design | A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 13 of the 22 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. 2017, 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?
This device is a diagnostic imaging system for 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). CT…
Read the full statement (377 words)
This device is a diagnostic imaging system for 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). CT data is
applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated
acquisitions. This system is intended for patients of all ages.
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:
• 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.
• Radiation therapy treatment planning and interventional radiology procedures.
The system 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 data sets 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.
This scanner is also intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early
detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion
criteria of programs / protocols that have been approved and published by either a governmental body or professional
medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011;
365:395-409) and subsequent literature, for further information.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172406: Ingenuity TF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172406
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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