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510(k) K251110

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound, LLC — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
April 11, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K250886 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound (June 18, 2025)
  • K243793 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound (May 21, 2025)
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  • K242670 — Lumify Diagnostic Ultrasound System (May 8, 2025)
  • K250030 — Flash Ultrasound System 5100 Point of Care (April 28, 2025)
  • K250177 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound (April 10, 2025)
  • K241659 — Ultrasound Workspace (UWS 6.0) (February 10, 2025)

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