Cleared Special

AVISO OPHTHALMIC ULTRASOUND SYSTEM (K051851) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K051851 · Quantel Medical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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

All 192
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K051851.
DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K060949 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2006
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900
K053346 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2005
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K052113 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2005
DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K043563 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2005
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · Siemens Medical Solutions USA, Inc. · Oct 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · Siemens Medical Solutions USA, Inc. · Mar 2004