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510(k) K191007

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems by Supersonic Imagine — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2019
Date Received
April 16, 2019
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)
  • 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)
  • K132274 — AIXPLORER (September 24, 2013)

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