Home / 510(k) Clearances / K232988

510(k) K232988

Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System by Canon Medical Systems Corporation — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
September 22, 2023
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 Canon Medical Systems Corporation

  • K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (March 27, 2026)
  • K260078 — Aquilion ServeSP (TSX-307B) V2.0 (March 13, 2026)
  • K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (March 10, 2026)
  • K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System (January 20, 2026)
  • K251370 — Cartesion Prime (PCD-1000A/3) V10.21 (December 1, 2025)
  • K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (October 31, 2025)
  • K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (October 10, 2025)
  • K251645 — Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S (September 26, 2025)
  • K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing (July 22, 2025)
  • K243398 — CT Scanner TSX-501R/1 V11.1 (June 20, 2025)

Other clearances for product code IYN

  • K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (April 6, 2026)
  • K252709 — Wireless Probe Type Ultrasound Scanner (April 2, 2026)
  • K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound (March 27, 2026)
  • K254099 — EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO (March 27, 2026)
  • K252148 — Butterfly Gestational Age Tool (March 27, 2026)
  • K260673 — LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Powe (March 24, 2026)
  • K252433 — Sonio Detect (v3) (March 16, 2026)
  • 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)