Incisive CT on Trailer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211168 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips Incisive CT on Trailer is a whole-body computed tomography (CT) X-ray system, classified under System, X-ray, Tomography, Computed (product code JAK). It features a continuously rotating X-ray tube, detectors, and a gantry with multi-slice capability to acquire cross-sectional imaging data.
This device is designed for use in mobile or temporary clinical settings, supplied as a trailer-mounted system. It is regulated under FDA 510(k) clearance (K211168) and MDR, with a traditional review process through the Radiology Advisory Committee. The system is intended for single-use or reusable applications as specified by the manufacturer, though sterility and MRI safety details are not provided in the available data.
Frequently asked questions
What types of clinical environments is the Philips Incisive CT on Trailer designed for?
The Philips Incisive CT on Trailer is specifically designed for mobile or temporary clinical settings, making it ideal for locations where a permanent CT scanner isn’t feasible. Its trailer-mounted configuration allows deployment in disaster zones, field hospitals, or remote areas where whole-body computed tomography imaging is needed on-site.
How is the Philips Incisive CT on Trailer classified under regulatory frameworks?
This device falls under the FDA product code JAK (System, X-ray, Tomography, Computed) and has received FDA 510(k) clearance (K211168) through a traditional review process, with input from the Radiology Advisory Committee (RA). It is also compliant with MDR (Medical Device Regulation) standards, ensuring alignment with both U.S. and EU regulatory requirements.
Is the Philips Incisive CT on Trailer intended for single-use or reusable applications?
The device’s single-use or reusable status depends on manufacturer specifications, as explicitly noted in the data. While the system itself is designed for repeated use in mobile settings, proper sterilization protocols must be followed if reuse is planned. The provided details do not specify sterility assurances, so users should confirm with Philips Healthcare for guidance on cleaning and reprocessing.
What imaging capabilities does the Philips Incisive CT on Trailer offer?
The system features a continuously rotating X-ray tube and multi-slice detectors, enabling high-resolution cross-sectional imaging across the entire body. This allows for detailed scans of internal structures, making it suitable for diagnostic evaluations in environments where traditional CT imaging isn’t available. The trailer-mounted design ensures portability without compromising performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips Incisive CT on Trailer (K211168) — FDA 510 (k) | Innolitics, K211168 - Philips Incisive CT on Trailer | FDA 510 (k), PDF November 22, 2021 Philips Healthcare (Suzhou) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211168 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
Sources (2)
- FDA 510(k) K211168 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026