Cleared Traditional

K913732 - MAMMOGRAPHIC X-RAY SYSTEM

K913732 is an FDA 510(k) clearance for MAMMOGRAPHIC X-RAY SYSTEM, manufactured by Lorad Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K913732 · Lorad Medical Systems, Inc. · Radiology device
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Feb 1992
Decision
167d
Days
Class 2
Risk

K913732 is an FDA 510(k) clearance for the MAMMOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad Medical Systems, Inc. (Danbury, US). The FDA issued a Cleared decision on February 3, 1992 after a review of 167 days - an extended review 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: 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 Medical Systems, Inc. devices

FDA 510(k) Submission Details - K913732

510(k) Number K913732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date February 03, 1992
Days to Decision 167 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 107d · This submission: 167d
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 111
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K913732.
TILTING MAG
K921896 · Continental X-Ray Corp. · Aug 1992
CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO
K915201 · Bennett X-Ray Corp. · Jul 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · Elscint, Inc. · Feb 1992
SENOGRAPHE DMR/SMR/DM
K913418 · General Electric Co. · Jan 1992
PHILIPS MAMMODIAGNOST BC
K913845 · Philips Medical Systems, Inc. · Dec 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
K914328 · Siemens Medical Solutions USA, Inc. · Dec 1991