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510(k) K250886

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
June 18, 2025
Date Received
March 25, 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

Other clearances by Philips Ultrasound, LLC

  • K252557 — Lumify Diagnostic Ultrasound System (December 22, 2025)
  • K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound (October 9, 2025)
  • K251455 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound (July 24, 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)
  • K241659 — Ultrasound Workspace (UWS 6.0) (February 10, 2025)

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  • K253366 — LOGIQ Fortis (January 7, 2026)
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  • K252557 — Lumify Diagnostic Ultrasound System (December 22, 2025)
  • K252498 — Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 (December 5, 2025)