Cleared Special

MAMEX (K993740) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 107d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 18
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K993740.
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
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