Cleared Special

AVISO OPHTHALMIC ULTRASOUND SYSTEM

K051851 · Quantel Medical · Radiology
Aug 2005
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K051851 is an FDA 510(k) clearance for the AVISO OPHTHALMIC ULTRASOUND SYSTEM, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on August 3, 2005, 26 days after receiving the submission on July 8, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K051851 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2005
Decision Date August 03, 2005
Days to Decision 26 days
Submission Type Special
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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