Cleared Traditional

K102027 - AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102027 · Quantel Medical S.A. · Radiology device
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Dec 2010
Decision
156d
Days
Class 2
Risk

K102027 is an FDA 510(k) clearance for the AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Quantel Medical S.A. (Bozeman, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 156 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantel Medical S.A. devices

Submission Details

510(k) Number K102027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2010
Decision Date December 22, 2010
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 107d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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