Cleared Special

K992037 - MAMEX

K992037 is an FDA 510(k) clearance for MAMEX, manufactured by Del Medical Imaging Corp.. The device is a Class 2 Radiology device with product code IZH cleared through the Special 510(k) pathway after a 44-day FDA review.

K992037 · Del Medical Imaging Corp. · Radiology device
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Jul 1999
Decision
44d
Days
Class 2
Risk

K992037 is an FDA 510(k) clearance for the MAMEX. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Del Medical Imaging Corp. (Franklin Park, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 44 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 Del Medical Imaging Corp. devices

FDA 510(k) Submission Details - K992037

510(k) Number K992037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date July 30, 1999
Days to Decision 44 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
63d faster than avg
Panel avg: 107d · This submission: 44d
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 92
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K992037.
DELTA 16 TACT
K001171 · Instrumentarium Imaging, Inc. · May 2000
LORAD 1-650 (INTERNATIONAL 650)
K992280 · Lorad Corp. · Sep 1999
PLANMED SOPHIE AND SOPHIE CLASSIC
K991826 · Planmed OY · Aug 1999
BIOPSY-DIGIT
K990192 · Sitco, Inc. · Mar 1999
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091 · Trex Medical Corp. · Feb 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · Trex Medical Corp. · Feb 1999