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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K252992
Device Name CT Rembra RT; CT Areta RT; CT Rembra
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Tiffany Zhang
Correspondent
Philips Medical Systems Technologies , Ltd.
# 258, Zhongyuan Rd., Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Tiffany Zhang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/18/2025
Decision Date 03/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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