Home / 510(k) Clearances / K091970

510(k) K091970

AIXPLORER ULTRASOUND SYSTEM by Supersonic Imagine — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2009
Date Received
July 1, 2009
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 Supersonic Imagine

  • K242223 — SuperSonic HepaVu (September 20, 2024)
  • K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SU (October 28, 2022)
  • K203645 — Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERS (June 29, 2021)
  • K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Super (December 29, 2020)
  • K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (October 25, 2019)
  • K180572 — AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 2 (May 29, 2018)
  • K173021 — Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (January 9, 2018)
  • K171105 — AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (July 11, 2017)
  • K161999 — Aixplorer (November 16, 2016)
  • K142100 — AIXPLORER (November 20, 2014)

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)