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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 K223311
Device Name Philips CT 3500
Applicant
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Xu Diana
Correspondent
Philips Healthcare (Suzhou) Co., Ltd
No.258, ZhongYuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Xu Diana
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/28/2022
Decision Date 12/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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