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510(k) K250543

Voluson™ Performance 16; Voluson™ Performance 18 by GE Medical Systems Ultrasound and Primary Care Diagnostics — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2025
Date Received
February 24, 2025
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 GE Medical Systems Ultrasound and Primary Care Diagnostics

  • K253370 — LOGIQ Totus (January 8, 2026)
  • K253366 — LOGIQ Fortis (January 7, 2026)
  • K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (November 24, 2025)
  • K251985 — LOGIQ E10 (October 29, 2025)
  • K251963 — LOGIQ E10s (October 29, 2025)
  • K251322 — Venue; Venue Go; Venue Fit; Venue Sprint (July 25, 2025)
  • K251342 — EchoPAC Software Only / EchoPAC Plug-in (July 16, 2025)
  • K251169 — Vivid Pioneer (July 10, 2025)
  • K250087 — Vscan Air (May 1, 2025)
  • K243620 — Vivid iq (February 11, 2025)

Other clearances for product code IYN

  • K260595 — Sonosite iLOOK Ultrasound System (March 10, 2026)
  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • 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)