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510(k) K102041

AIXPLORER by Supersonic Imagine — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2010
Date Received
July 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Supersonic Imagine

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  • 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 ITX

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  • K250524 — Mendaera Guidance System (July 2, 2025)
  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K241662 — Ultrasound Transducer Cover (August 30, 2024)
  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K241615 — Transducer Probe Cover (July 3, 2024)
  • K233109 — TP Pivot Pro™ Needle Guide (December 22, 2023)
  • K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (December 13, 2023)
  • K231783 — VitroPRO (November 14, 2023)