Cleared Traditional

LORAD M-III (K934625) - FDA 510(k) Clearance

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

K934625 · Lorad Corp. · Radiology device
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Jan 1994
Decision
123d
Days
Class 2
Risk

K934625 is an FDA 510(k) clearance for the LORAD M-III. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad Corp. (Danbury, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - 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 Lorad Corp. devices

Submission Details

510(k) Number K934625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1993
Decision Date January 28, 1994
Days to Decision 123 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
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 - IZH System, X-ray, Mammographic

All 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K934625.
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · Philips Medical Systems (Cleveland), Inc. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995
MAMMOMAT 300 AND MAMMOMAT 3000
K932672 · Siemens Medical Solutions USA, Inc. · Sep 1994
CHENOWETH-FRANK RADIOPATHOLOGICAL GRID
K933754 · Cook, Inc. · Sep 1993
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · Siemens Medical Solutions USA, Inc. · Dec 1991