510(k) · Cleared
Recalled · Class II · 2015Ingenuity TF Pet/MR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Cleveland) · OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Cleared on Nov 23, 2011 as substantially equivalent to K052640 (Philips Medical Systems (Cleveland), Inc., 2005) and 1 other predicate after a 362-day review. Its family tree reaches back 9 generations to 1993. 4 of the 30 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times.
- Decided
- Nov 23, 2011
- Review
- 362 days
- Class
- Class II
- Product code
- OUO
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 9 generations to K930090 (1993). 29 ancestors in all. No later device cites it as a predicate yet. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- 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 deviceK103483 Ingenuity TF Pet/MRPhilips Healthcare (Cleveland) · 2011
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 deviceK103483 Ingenuity TF Pet/MRPhilips Healthcare (Cleveland) · 2011
Class I recalls in this family
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) | K103483 | Ingenuity TF Pet/MR | Philips Healthcare (Cleveland) | 2011 | — |
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 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 1 |
| 2005 | 2 | 2 |
| 2007 | 1 | 1 |
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.
4 devices in this family have a Class I recall. 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 OUO device
- #1 K253963 Cubresa BrainPETscore 15.6 · 14 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…appropriate safety standards and/or draft standards are used PREDICATE DEVICE(S) The predicate device is the GEMINI IF PET/CT (Raptor), K052640 cleared by FDA on October 7, 2005; and the Achieva 3.OT MRI, K063 559 cleared by FDA on January 4, 2007. INTENDED USE The devi… | 2005 |
| * | K063559 | Achieva, Intera and Panorama 1.0T, Release 2.5Summary page 1…raft standards are used PREDICATE DEVICE(S) The predicate device is the GEMINI IF PET/CT (Raptor), K052640 cleared by FDA on October 7, 2005; and the Achieva 3.OT MRI, K063 559 cleared by FDA on January 4, 2007. INTENDED USE The device is a diagnostic imaging system for fixed or mobile installations th… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2015 | Class II | Z-2491-2015 | Software design | Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruction Server (PRS) database may lock up after an MR acquisition is completed and before a PET acquisition is begun, even though no actual… |
| Mar 11, 2015 | Class II | Z-1682-2015 | Software in the Use Environment | It was noticed that the spectroscopy voxel map did not align with the anatomical images of the phantom. This resulted in incorrect orientation of the Chemical Shift Imaging (CSI) data. |
| Mar 6, 2015 | Class II | Z-1780-2015 | 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. |
| Apr 13, 2012 | Not classified | Z-1646-2012 | Software design | Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063559Achieva, Intera and Panorama 1.0T, Release 2.5Philips Medical Systems · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
- K052078Achieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 13 Class I recalls
- K041602Panorama 1.0TPhilips Medical Systems North America, Inc. · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 20 of the 29 ancestors have a recall of any class; 4 have a Class I recall.
- 5 other devices also cite its predicate K052640.
How does its category compare?
All OUO devicesOUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OUO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OUO
84in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OUO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUO
1in 2021
MAUDE reports naming product code OUO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 1 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 84 | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to ionizing radiation, only the dose contribution from the PET radiopharmaceutical. The MRI subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces…
Read the full statement (289 words)
The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to ionizing radiation, only the dose contribution from the PET radiopharmaceutical. The MRI subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portions of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data.
Image processing and display work stations provide software applications to process, analyze, display, quantify and interpret medical images/data via a single user interface. The PET and MRI 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 professional 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.
The device includes software that provides a quantified analysis of regional cerebral activity from the PET images.
The MRI provides capabilities to perform interventional procedures in the head, body, and extremities which may be facilitated by MR techniques, such as real time imaging, such procedures must be performed with MRI compatible instrumentation as selected and evaluated by the clinical user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103483: Ingenuity TF Pet/MR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103483
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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