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510(k) K242020

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
July 11, 2024
Clearance Type
Traditional
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

Other clearances by Philips Ultrasound, LLC

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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)
  • K242519 — Lumify Diagnostic Ultrasound System (May 15, 2025)
  • K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound (May 9, 2025)
  • 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)

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