Cleared Special

K993740 - MAMEX

K993740 is an FDA 510(k) clearance for MAMEX, manufactured by Medical Systems Group. The device is a Class 2 Radiology device with product code IZH cleared through the Special 510(k) pathway after a 22-day FDA review.

K993740 · Medical Systems Group · Radiology device
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Nov 1999
Decision
22d
Days
Class 2
Risk

K993740 is an FDA 510(k) clearance for the MAMEX. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Medical Systems Group (Franklin Park, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Systems Group devices

FDA 510(k) Submission Details - K993740

510(k) Number K993740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1999
Decision Date November 26, 1999
Days to Decision 22 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 103
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K993740.
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
K000976 · Instrumentarium Imaging, Inc. · Jun 2000
DELTA 16 TACT
K001171 · Instrumentarium Imaging, Inc. · May 2000
DIGITEC TWO STAGE COMPRESSION KIT
K993681 · Digitec Medical Service Corp. · Dec 1999
LORAD 1-650 (INTERNATIONAL 650)
K992280 · Lorad Corp. · Sep 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · Planmed OY · Aug 1999
MAMEX
K992037 · Del Medical Imaging Corp. · Jul 1999