Cleared Traditional

Axialis Ophthalmic Ultrasound System

K213254 · Quantel Medical · Radiology
Nov 2021
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K213254 is an FDA 510(k) clearance for the Axialis Ophthalmic Ultrasound System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Quantel Medical (Cournon D' Auvergne-Cedex, FR). The FDA issued a Cleared decision on November 15, 2021, 46 days after receiving the submission on September 30, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K213254 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2021
Decision Date November 15, 2021
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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