Cleared Traditional

K012803 - AL-2000 COMBINED BIOMETER AND PACHYMETER

K012803 is an FDA 510(k) clearance for AL-2000 COMBINED BIOMETER AND PACHYMETER, manufactured by Tomey Corp.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K012803 · Tomey Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
230d
Days
Class 2
Risk

K012803 is an FDA 510(k) clearance for the AL-2000 COMBINED BIOMETER AND PACHYMETER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Tomey Corp. (North Reading, US). The FDA issued a Cleared decision on April 8, 2002 after a review of 230 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.

FDA 510(k) Submission Details - K012803

510(k) Number K012803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2001
Decision Date April 08, 2002
Days to Decision 230 days
Submission Type Traditional
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
123d slower than avg
Panel avg: 107d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

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 878
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K012803.
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K012727 · Carl Zeiss Ophthalmic Systems, Inc. · Jan 2002
K012803 · AL-2000 COMBINED BIOMETER AND PACHYMETER
Download PDF FDA Summary Tomey Corp.