# K160743: Philips Ingenuity CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 8, 2016 after 144 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 10 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033326: Philips Plus Computed Tomography System, Philips Medical Systems, Inc. (2003) Summary page 6.

## Most influential descendants
- K180015: Philips Incisive CT (2018), 7 descendants of its own
- K212441: Philips Incisive CT (2022), 3 descendants of its own
- K232491: CT 5300 (2024), 1 descendant of its own
- K211168: Philips Incisive CT on Trailer (2021), 1 descendant of its own
- K252992: CT Rembra RT; CT Areta RT; CT Rembra (2026), 0 descendants of its own

## Recalls of this device
- Aug 7, 2026 · Class II · Z-3042-2026: Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
- Jun 11, 2026 · Class II · Z-2652-2026: The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acqui
- Aug 13, 2025 · Class II · Z-2600-2025: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
- Jun 8, 2021 · Class II · Z-2315-2021: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recomme
- Jun 8, 2021 · Class II · Z-2316-2021: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recomme
- May 1, 2021 · Class II · Z-1984-2021: 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-2188-2019: 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 24, 2019 · Class II · Z-2186-2019: 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 24, 2019 · Class II · Z-2187-2019: 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 
- Mar 28, 2018 · Class II · Z-2277-2018: A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or user
- Mar 28, 2018 · Class II · Z-2274-2018: A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or user
- Mar 28, 2018 · Class II · Z-2275-2018: A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or user
- Nov 10, 2017 · Class II · Z-0390-2018: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system 
- Nov 10, 2017 · Class II · Z-0391-2018: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system 
- Oct 6, 2017 · Class II · Z-0520-2018: Numerous issues related to software Brilliance iCT 4.1.6 software version.
- Oct 6, 2017 · Class II · Z-0518-2018: Numerous issues related to software Brilliance iCT 4.1.6 software version.
- Oct 6, 2017 · Class II · Z-0519-2018: Numerous issues related to software Brilliance iCT 4.1.6 software version.
- Oct 6, 2017 · Class II · Z-0521-2018: Numerous issues related to software Brilliance iCT 4.1.6 software version.
- Nov 12, 2016 · Class II · Z-0695-2017: Software error due to the filament on timer
- Nov 12, 2016 · Class II · Z-0697-2017: Software error due to the filament on timer
- Nov 12, 2016 · Class II · Z-0696-2017: Software error due to the filament on timer
- Oct 13, 2016 · Class III · Z-0595-2017: The product label does not include the correct current rating.
- Oct 13, 2016 · Class III · Z-0597-2017: The product label does not include the correct current rating.
- Oct 13, 2016 · Class III · Z-0596-2017: The product label does not include the correct current rating.

## Indications for use
The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These scanners are 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.

Source page: https://510kreport.com/device/K160743
Methodology: https://510kreport.com/methodology