CT Rembra RT; CT Areta RT— 510(k) K252992
Substantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.
FDA 510(k) clearance K252992 for CT Rembra RT; CT Areta RT, Substantially Equivalent on 2026-03-23. Applicant: Philips Healthcare (Suzhou) Co., Ltd.. Device class: 2.
Summary
Philips Healthcare (Suzhou) has three CT names in this record: CT Rembra RT, CT Areta RT and CT Rembra. They're filed under JAK, computed tomography x-ray systems.
Class II, 21 CFR 892.1750. It was a Traditional 510(k), and Radiology is both the classification panel and the review panel.
Philips Healthcare (Suzhou) filed from Suzhou, China. The decision came 186 calendar days after FDA received it (September 18, 2025 to March 23, 2026).
Clearance details
- Device name as filed
- CT Rembra RT; CT Areta RT; CT Rembra
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- Product code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code JAK
view allMore clearances from Philips Healthcare (Suzhou) Co., Ltd.
view allAdverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.