Cleared Traditional

COMPACT TOUCH Ophthalmic Ultrasound System

K180265 · Quantel Medical · Radiology
Mar 2018
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K180265 is an FDA 510(k) clearance for the COMPACT TOUCH 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 March 2, 2018, 30 days after receiving the submission on January 31, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K180265 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2018
Decision Date March 02, 2018
Days to Decision 30 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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