# K103483: Ingenuity TF Pet/MR

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Cleveland)
- Decided: Nov 23, 2011 after 362 days
- Product code: OUO (Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930090 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052640: Gemini Raptor, Philips Medical Systems (Cleveland), Inc. (2005) Summary page 1.
- K063559: Achieva, Intera and Panorama 1.0T, Release 2.5, Philips Medical Systems (2007) Summary page 1.

## Recalls of this device
- Jul 23, 2015 · Class II · Z-2491-2015: 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
- Mar 11, 2015 · Class II · Z-1682-2015: 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: 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, overh
- Apr 13, 2012 · Not classified · Z-1646-2012: 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-con

## Indications for use
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.

Source page: https://510kreport.com/device/K103483
Methodology: https://510kreport.com/methodology