# K123599: Ingenuity Digital Pet/CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Cleveland)
- Decided: Jul 12, 2013 after 233 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 5 (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). 22 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 27 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 2.

## Most influential descendants
- K210880: Vereos PET/CT (2021), 2 descendants of its own
- K251401: PennPET Explorer Positron Emission Tomograph (2025), 0 descendants of its own
- K231420: Aura 10 PET/CT (2023), 0 descendants of its own
- K211764: Vereos PET/CT (2021), 0 descendants of its own

## Recalls of this device
- May 1, 2021 · Class II · Z-1988-2021: 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
- Jun 24, 2019 · Class II · Z-2194-2019: 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 
- Jun 3, 2019 · Class II · Z-1929-2019: The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.
- Sep 4, 2018 · Class II · Z-0302-2019: Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may re
- May 21, 2018 · Class II · Z-2496-2018: The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.

## Indications for use
The Philips Ingenuity Digital PET/CT System is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of x-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purpose of detecting, localizing, diagnosing, staging, re-staging and follow-up for monitoring therapy response of various diseases in oncology, cardiology and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools including application of the CT scanner for diagnosis and for use in radiation therapy planning.

Source page: https://510kreport.com/device/K123599
Methodology: https://510kreport.com/methodology