Home / 510(k) Clearances / K243937

510(k) K243937

Accuro 3S by Rivanna Medical, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2025
Date Received
December 20, 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 Rivanna Medical, Inc.

  • K250469 — Accuro® 3S Needle Guide Kit (June 13, 2025)
  • K171594 — Accuro (October 20, 2017)
  • K132736 — ACCURO 3000 ULTRASOUND SCANNER (March 11, 2014)

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)
  • K243479 — EchoGuide (Version 1) (April 23, 2025)
  • K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (November 19, 2024)