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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K211597
Device Name EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Applicant
Philips Medical Systems
22100 Bothell Everett HWY
Bothell,  WA  98021
Applicant Contact Brenna Loufek
Correspondent
Philips Medical Systems
22100 Bothell Everett HWY
Bothell,  WA  98021
Correspondent Contact Tamara Daniels
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   QIH  
Date Received05/24/2021
Decision Date 09/08/2021
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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