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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 K232491
Device Name CT 5300
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park,
Suzhou Jiangsu, CHINA, 215024
Suzhou,  CN 215024
Applicant Contact An Shiguang
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park,
Suzhou Jiangsu, CHINA, 215024
Suzhou,  CN 215024
Correspondent Contact An Shiguang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/17/2023
Decision Date 05/03/2024
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
Recalls CDRH Recalls
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