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510(k) K243880

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) by Wuxi Hisky Medical Technologies Co., Ltd. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2025
Date Received
December 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Wuxi Hisky Medical Technologies Co., Ltd.

  • K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/F (October 1, 2025)
  • K243711 — Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging Sys (July 24, 2025)
  • K200136 — Shear Wave Quantificational Ultrasound Diagnostic System (March 17, 2020)
  • K173595 — Shear Wave Quantificational Ultrasound Diagnostic System (June 22, 2018)

Other clearances for product code IYO

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  • K253714 — IntraSight Plus (February 24, 2026)
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  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)
  • K243937 — Accuro 3S (May 23, 2025)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)
  • K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (November 19, 2024)