Incisive CT
Incisive CT is a whole-body computed tomography system that reconstructs X-ray transmission measurements into cross-sectional images. A continuously rotating tube and detector array acquire…
Incisive CT is a whole-body computed tomography system that reconstructs X-ray transmission measurements into cross-sectional images. A continuously rotating tube and detector array acquire data from different angles as the patient couch moves through the gantry.
The system has a 72 cm bore and a 50 cm scan field of view. The console controls acquisition and supports image reconstruction, display, post-processing, storage and review.
Listed Item
The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Clinical Applications
It is indicated for head, whole body, cardiac and vascular CT in patients of all ages. Low-dose lung cancer screening is supported only within established eligibility criteria of published screening programs or protocols.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
8510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Philips Healthcare (Suzhou) Co., Ltd., China |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K180015 |
| Record published | 2021-12-30 |
| Record revised | 2025-07-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature -20 to 50 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -15 to 45 °C; Storage environment humidity 20 to 80 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Incisive CT | In distribution | |
| Incisive CT | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252992 | 2026-03-23 |
| K232491 | 2024-05-03 |
| K223311 | 2022-12-22 |
| K212441 | 2022-04-27 |
| K211168 | 2021-11-22 |
| K203514 | 2021-06-17 |
| K191136 | 2019-07-29 |
| K180015 | 2018-03-20 |
Recalls Naming This Product
24 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | 510(k) number | 2025-12-03 | Class II | Radiation Control for Health and Safety Act | Potential for incomplete scan due to unstable connection inside of floating sensor. | 35 | |
| Philips North America LLC | 510(k) number | 2025-10-29 | Class II | Under Investigation by firm | 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 Incisive CT systems during rotation. Other com | 2341 units | |
| Philips Medical Systems Technologies Ltd | 510(k) number | 2025-09-25 | Class II | Under Investigation by firm | 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 (Dose Right index)/ DOM (Dose Modulation), t | 105 units | |
| Philips Medical Systems Technologies Ltd | 510(k) number | 2025-09-25 | Class II | Under Investigation by firm | 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 (Dose Right index)/ DOM (Dose Modulation), t | 165 units | |
| Philips Medical Systems Technologies Ltd | 510(k) number | 2025-09-25 | Class II | Under Investigation by firm | 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 (Dose Right index)/ DOM (Dose Modulation), t | 1 unit (OUS only) | |
| Philips North America LLC | 510(k) number | 2024-04-15 | Class II | Under Investigation by firm | 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 within the Incisive CT system during ro | 18 units | |
| Philips North America LLC | UDI-DI | 2024-04-15 | Class II | Under Investigation by firm | 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 within the Incisive CT system during ro | 155 units | |
| Philips North America LLC | 510(k) number | 2023-12-07 | Class II | Component design/selection | 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 loss of the ECG signal. Loss of ECG sign | 55 US; 1029 ROW | |
| Philips Healthcare Group | 510(k) number | 2023-08-02 | Class II | Radiation Control for Health and Safety Act | 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: Use of aborted surview for scan planning | 140 systems | |
| Philips North America LLC | 510(k) number | 2023-04-25 | Class II | Under Investigation by firm | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted a | 36 US; 610 OUS | |
| Philips North America LLC | 510(k) number | 2023-04-25 | Class II | Under Investigation by firm | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted a | 20 units OUS | |
| Philips North America LLC | 510(k) number | 2023-04-25 | Class II | Under Investigation by firm | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted a | 53 units OUS | |
| Philips North America LLC | 510(k) number | 2023-04-25 | Class II | Under Investigation by firm | Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted a | 6 units OUS | |
| Philips Headquarters Cambridge | 510(k) number | 2023-04-12 | Class II | Software design | 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 required | 7 units US and 76 unit OUS | |
| Philips Headquarters Cambridge | 510(k) number | 2023-04-12 | Class II | Software design | 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 required | 22 units | |
| Philips Headquarters Cambridge | 510(k) number | 2023-04-12 | Class II | Software design | 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 required | 1 unit | |
| Philips Headquarters Cambridge | 510(k) number | 2023-04-12 | Class II | Software design | 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 required | 5 units | |
| Philips North America LLC | 510(k) number | 2023-03-20 | Class II | Under Investigation by firm | 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 | 10 units US; 36 units OUS | |
| Philips North America LLC | 510(k) number | 2023-03-20 | Class II | Under Investigation by firm | 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 | 3 units US ;2 units OUS | |
| Philips Healthcare (Suzhou) Co., Ltd. | 510(k) number | 2022-12-23 | Class II | Software design | 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 occur on perfusion images, 2. Orientation | 828 | |
| Philips North America LLC | 510(k) number | 2022-03-29 | Class II | Software design | 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. | 330 units | |
| Philips Healthcare (Suzhou) Co., Ltd. | 510(k) number | 2021-02-24 | Class II | Process control | Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position. | 109 systems | 2023-02-17 |
| Philips North America LLC | 510(k) number | 2021-02-22 | Class II | Process control | Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the | 105 units (1 US and 104 OUS) | 2023-02-09 |
| Philips North America LLC | 510(k) number | 2020-12-24 | Class II | Software design | Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured | 428 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 2026-06-26 | Class II | Radiation Control for Health and Safety Act | Potential of failing to trigger clinical scan during Bolus Tracking. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.