Cleared Traditional

K063433 - ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 (FDA 510(k) Clearance)

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

K063433 · Meda , Ltd. · Radiology device
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Jan 2007
Decision
77d
Days
Class 2
Risk

K063433 is an FDA 510(k) clearance for the ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Meda , Ltd. (Cleveland, US). The FDA issued a Cleared decision on January 29, 2007 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meda , Ltd. devices

Submission Details

510(k) Number K063433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date January 29, 2007
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
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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