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510(k) K253221

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) by Eieling Technology (Shenzhen) Limited — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2026
Date Received
September 29, 2025
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 Eieling Technology (Shenzhen) Limited

  • K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (November 19, 2024)

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  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • 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)
  • K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (November 19, 2024)