Cleared Traditional

K992280 - LORAD 1-650 (INTERNATIONAL 650)

K992280 is an FDA 510(k) clearance for LORAD 1-650 (INTERNATIONAL 650), manufactured by Lorad Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K992280 · Lorad Corp. · Radiology device
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Sep 1999
Decision
58d
Days
Class 2
Risk

K992280 is an FDA 510(k) clearance for the LORAD 1-650 (INTERNATIONAL 650). 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 September 3, 1999 after a review of 58 days - a notably fast clearance cycle.

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: 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 Lorad Corp. devices

FDA 510(k) Submission Details - K992280

510(k) Number K992280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1999
Decision Date September 03, 1999
Days to Decision 58 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
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K992280.
DELTA 32 AND DELTA 32 TACT
K002472 · Instrumentarium Imaging, Inc. · Nov 2000
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · Instrumentarium Imaging, Inc. · Jun 2000
DELTA 16 TACT
K001171 · Instrumentarium Imaging, Inc. · May 2000
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · Planmed OY · Aug 1999
MAMEX
K992037 · Del Medical Imaging Corp. · Jul 1999
BIOPSY-DIGIT
K990192 · Sitco, Inc. · Mar 1999