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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 K200179
Device Name Collaboration Live
Applicant
Philips Healthcare
22100 Bothell Everett Highway
bothell,  WA  98021 -8431
Applicant Contact paul elias
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  
Subsequent Product Codes
IYN   IYO  
Date Received01/24/2020
Decision Date 02/18/2020
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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