Cleared Traditional

K960381 - MAM-CH22S WITH AUTOMATIC FILTER SELECTI...

K960381 is the FDA 510(k) clearance for MAM-CH22S WITH AUTOMATIC FILTER SELECTI... by Elscint, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K960381 · Elscint, Inc. · Radiology device
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Apr 1996
Decision
94d
Days
Class 2
Risk

K960381 is an FDA 510(k) clearance for the MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Elscint, Inc. (Hackensack, US). The FDA issued a Cleared decision on April 29, 1996 after a review of 94 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 Elscint, Inc. devices

Submission Details

510(k) Number K960381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1996
Decision Date April 29, 1996
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
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 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K960381.
MAMMOTEST ADAPTER DRIVER
K973400 · Fischer Imaging Corp. · Nov 1997
GLORY
K970680 · Elscint, Inc. · Jun 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM
K941353 · Elscint, Inc. · Mar 1995