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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, Stationary
510(k) Number K233662
Device Name Radiography 7300 C
Applicant
Philips Medical Systems DMC GmbH
Roentgenstrasse 24
Hamburg,  DE 22335
Applicant Contact Ming Xiao
Correspondent
Philips Medical Systems DMC GmbH
Roentgenstrasse 24
Hamburg,  DE 22335
Correspondent Contact Ming Xiao
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received11/15/2023
Decision Date 06/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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