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510(k) K211597

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System by Philips Medical Systems — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2021
Date Received
May 24, 2021
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

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  • K192875 — Philips Biosensor BX100 (April 16, 2020)
  • K183387 — M3290B Patient Information Center iX (August 6, 2019)
  • K180017 — MX40 Release C.01 (July 24, 2018)
  • K172226 — MX40 Release B.07 (November 9, 2017)
  • K163584 — M3290B Philips IntelliVue Information Center iX (July 7, 2017)

Other clearances for product code IYN

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  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; H (January 5, 2026)
  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K250959 — BioticsAI (December 22, 2025)
  • 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)