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510(k) K201597

Liver Incytes, Model 1005 by Sonic Incytes — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2020
Date Received
June 12, 2020
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

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  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
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  • K251728 — Velacur One (LI-1100) (June 26, 2025)
  • K243880 — Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini (June 17, 2025)
  • K243937 — Accuro 3S (May 23, 2025)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)