Cleared Traditional

K905748 - MAMEX DC AMI SL12/MG15 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905748 · Soredex, Inc. · Radiology device
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Mar 1991
Decision
71d
Days
Class 2
Risk

K905748 is an FDA 510(k) clearance for the MAMEX DC AMI SL12/MG15. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Soredex, Inc. (Sf-00511 Helsinki Finland, FI). The FDA issued a Cleared decision on March 7, 1991 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Soredex, Inc. devices

Submission Details

510(k) Number K905748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1990
Decision Date March 07, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 107d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.