# K212441: Philips Incisive CT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Healthcare (Suzhou) Co., Ltd.
- Decided: Apr 27, 2022 after 266 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930090 (1993). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160743: Philips Ingenuity CT, Philips Medical Systems (Cleveland), Inc. (2016) Summary page 4.
- K180015: Philips Incisive CT, Philips Healthcare (Suzhou) Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K232491: CT 5300 (2024), 1 descendant of its own
- K252992: CT Rembra RT; CT Areta RT; CT Rembra (2026), 0 descendants of its own
- K223311: Philips CT 3500 (2022), 0 descendants of its own

## Recalls of this device
- Jun 26, 2026 · Class II · Z-2988-2026: Potential of failing to trigger clinical scan during Bolus Tracking.
- Dec 3, 2025 · Class II · Z-1003-2026: Potential for incomplete scan due to unstable connection inside of floating sensor.
- Oct 29, 2025 · Class II · Z-0881-2026: If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisi
- Sep 25, 2025 · Class II · Z-0375-2026: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dos
- Sep 25, 2025 · Class II · Z-0376-2026: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dos
- Sep 25, 2025 · Class II · Z-0377-2026: Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dos
- Apr 15, 2024 · Class II · Z-1872-2024: Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located
- Dec 7, 2023 · Class II · Z-0719-2024: If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent 
- Aug 2, 2023 · Class II · Z-2520-2023: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: U
- Apr 12, 2023 · Class II · Z-1625-2023: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is requir
- Apr 12, 2023 · Class II · Z-1623-2023: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is requir
- Apr 12, 2023 · Class II · Z-1622-2023: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is requir
- Apr 12, 2023 · Class II · Z-1624-2023: Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is requir
- Mar 20, 2023 · Class II · Z-1585-2023: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
- Mar 20, 2023 · Class II · Z-1586-2023: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury
- Dec 23, 2022 · Class II · Z-0640-2024: Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occ
- Mar 29, 2022 · Class II · Z-0576-2024: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

## Indications for use
The Incisive 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 Incisive 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/K212441
Methodology: https://510kreport.com/methodology