FDA.report

510(k) K252992

Device
CT Rembra RT; CT Areta RT; CT Rembra
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
510(k) number
K252992
Product code
JAK
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-23
Date received
2025-09-18
Regulation
892.1750
Classification name
System, X-Ray, Tomography, Computed
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Tiffany Zhang
Address
# 258, Zhongyuan Rd., Suzhou Industrial Park Suzhou CN 215024 215024

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code JAK

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