CT 5300
The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and…
The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device includes data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
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 |
| Record published | 2024-11-11 |
| Record revised | 2025-07-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 80 % RH; Storage environment temperature -15 to 45 °C; Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT 5300 | In distribution |
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
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips North America LLC | UDI-DI | 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 | 6 units (OUS only) |
| Philips Medical Systems Technologies Ltd | UDI-DI | 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 |
Recalls
4 of these are 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-26 | Class II | Radiation Control for Health and Safety Act | Potential of failing to trigger clinical scan during Bolus Tracking. | ||
| 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 | |
| 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 | |
| 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 |
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.