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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, Mobile
510(k) Number K233678
Device Name Radiography 7000 M
Applicant
Philips Medical Systems Dmc GmbH
Röntgenstraße 24
Hamburg,  DE 22335
Applicant Contact Shalin Dave
Correspondent
Philips Medical Systems Dmc GmbH
Röntgenstraße 24
Hamburg,  DE 22335
Correspondent Contact Shalin Dave
Regulation Number892.1720
Classification Product Code
IZL  
Date Received11/16/2023
Decision Date 02/14/2024
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
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