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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 K212441
Device Name Philips Incisive CT
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Applicant Contact Shiguang An
Correspondent
Philips Healthcare (Suzhou) Co., Ltd.
No. 258, Zhongyuan Road, Suzhou Industrial Park
Suzhou,  CN 215024
Correspondent Contact Shiguang An
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/04/2021
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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