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510(k) K232459

Velacur by Sonic Incytes — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2023
Date Received
August 15, 2023
Clearance Type
Special
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 Sonic Incytes

  • K233977 — Velacur (September 4, 2024)
  • K223287 — Velacur (April 20, 2023)
  • K201597 — Liver Incytes, Model 1005 (July 31, 2020)

Other clearances for product code IYO

  • K253898 — QT Scanner 2000 Model A (March 4, 2026)
  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • 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)
  • 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)