Cleared Traditional

K941353 - MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM

K941353 is an FDA 510(k) clearance for MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIO..., 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 375-day FDA review.

K941353 · Elscint, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
375d
Days
Class 2
Risk

K941353 is an FDA 510(k) clearance for the MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM. 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 March 31, 1995 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K941353

510(k) Number K941353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date March 31, 1995
Days to Decision 375 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
268d slower than avg
Panel avg: 107d · This submission: 375d
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 K941353.
REAL TIME STEREOTIX
K941191 · GE Medical Systems · May 1995
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
K944978 · Bennett X-Ray Corp. · May 1995
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
K945962 · Bennett X-Ray Corp. · Apr 1995
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · Philips Medical Systems (Cleveland), Inc. · Mar 1995
ATHENA HFX
K945619 · Fischer Imaging Corp. · Mar 1995
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
K944816 · Philips Medical Systems (Cleveland), Inc. · Feb 1995