Cleared Traditional

K963913 - MD100 & MM150

K963913 is an FDA 510(k) clearance for MD100 & MM150, manufactured by Konica Medical Corp.. The device is a Class 1 Radiology device with product code EAM cleared through the Traditional 510(k) pathway after a 373-day FDA review.

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

FDA 510(k) Submission Details - K963913

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
266d slower than avg
Panel avg: 107d · This submission: 373d
Pathway characteristics
Predicate-based equivalence.

EAM Device Classification - Class 1, General Controls

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 29
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K963913.
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL
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K943823 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235 · Fujifilm Medical System U.S.A., Inc. · Aug 1994