Cleared Traditional

K960381 - MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION

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

K960381 · Elscint, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K960381

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.

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 110
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K960381.
PLANNED SOPHIED CLASSIC
K962105 · Planmed OY · Feb 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · Bennett X-Ray Corp. · Jan 1997
THE ROBOGUIDE
K961849 · Shai Syg Motion and Innovations, Ltd. · Aug 1996
DELTA 16
K955411 · Instrumentarium Imaging, Inc. · Mar 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · GE Medical Systems · Jan 1996
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
K951883 · Planmed OY · May 1995