Cleared Traditional

MD100 & MM150 (K963913) - FDA 510(k) Clearance

Class I Radiology device.

K963913 · Konica Medical Corp. · Radiology device
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Oct 1997
Decision
373d
Days
Class 1
Risk

K963913 is an FDA 510(k) clearance for the MD100 & MM150. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Konica Medical Corp. (New York, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1960 - 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 Konica Medical Corp. devices

Submission Details

510(k) Number K963913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date October 08, 1997
Days to Decision 373 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 107d · This submission: 373d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAM Screen, Intensifying, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EAM Screen, Intensifying, Radiographic

All 19
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K963913.
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K920200 · E.I. Dupont DE Nemours & Co., Inc. · May 1992
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CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
K900448 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990