Cleared Traditional

CM & CM DS-7 (K963914) - FDA 510(k) Clearance

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

K963914 · Konica Medical Corp. · Radiology device
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Oct 1997
Decision
373d
Days
Class 2
Risk

K963914 is an FDA 510(k) clearance for the CM & CM DS-7. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special 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 892.1850 - 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 K963914 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. No clinical trials required.

Device Classification

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 20
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K963914.
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K021903 · Eastman Kodak Company · Jul 2002
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KODAK MN-R 2000 CASSETTE
K961453 · Eastman Kodak Company · Jul 1996
CRONEX RADIATION THERAPY CASSETTE
K953724 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995