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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K240822
Device Name Image Management V15
Applicant
Philips Medical Systems Technologies
2 Hapnina Street, P.O. Box 46
Raanana Central,  IL 4321538
Applicant Contact Shlomit Brandis Kepler
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/25/2024
Decision Date 04/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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