Cleared Special

K051851 - AVISO OPHTHALMIC ULTRASOUND SYSTEM

K051851 is the FDA 510(k) clearance for AVISO OPHTHALMIC ULTRASOUND SYSTEM by Quantel Medical. It is a Class 2 Radiology device (product code IYO) cleared through the Special 510(k) pathway after a 26-day FDA review.

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

K051851 is an FDA 510(k) clearance for the AVISO OPHTHALMIC ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Quantel Medical (Hasbrouck Heights, US). The FDA issued a Cleared decision on August 3, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quantel Medical devices

Submission Details

510(k) Number K051851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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