Home / 510(k) Clearances / K213254

510(k) K213254

Axialis Ophthalmic Ultrasound System by Quantel Medical — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2021
Date Received
September 30, 2021
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 Quantel Medical

  • K251507 — INTEGRE LIO (February 6, 2026)
  • K232302 — Pocket III (April 26, 2024)
  • K220430 — Capsulo (May 12, 2022)
  • K201502 — Vitra 810 (August 6, 2020)
  • K191962 — Vitra 2 (December 5, 2019)
  • K183414 — ABSOLU (March 20, 2019)
  • K180265 — COMPACT TOUCH Ophthalmic Ultrasound System (March 2, 2018)
  • K170067 — Easyret (July 25, 2017)
  • K140336 — OPTIMUS FUSION: SLT, YAG AND YAG/SLT (June 25, 2014)
  • K130933 — SOLUTIS (August 2, 2013)

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)