Cleared Traditional

K921962 - LORAD DIGITAL SPOT MAMMOGRAPHY

K921962 is an FDA 510(k) clearance for LORAD DIGITAL SPOT MAMMOGRAPHY, 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 210-day FDA review.

K921962 · Lorad Medical Systems, Inc. · Radiology device
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Nov 1992
Decision
210d
Days
Class 2
Risk

K921962 is an FDA 510(k) clearance for the LORAD DIGITAL SPOT MAMMOGRAPHY. 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 November 23, 1992 after a review of 210 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 - K921962

510(k) Number K921962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date November 23, 1992
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
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 K921962.
AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS
K930282 · Elscint, Inc. · Aug 1993
CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR
K925725 · Bennett X-Ray Corp. · Feb 1993
PLANMED CYTOGUIDE
K923471 · Planmed OY · Nov 1992
PATIENT INFORMATION MANAGER (PIM)
K921986 · Continental X-Ray Corp. · Oct 1992
MOBILE ATHENA HF
K922454 · Fischer Imaging Corp. · Sep 1992
MAMMOSCAN
K923061 · Fischer Imaging Corp. · Sep 1992