Cleared Traditional

K941600 - MT-300 CASSETTE HOLDER

K941600 is the FDA 510(k) clearance for MT-300 CASSETTE HOLDER by Medtec, Inc.. It is a Class 2 Radiology device (product code IXA) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K941600 · Medtec, Inc. · Radiology device
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Sep 1994
Decision
168d
Days
Class 2
Risk

K941600 is an FDA 510(k) clearance for the MT-300 CASSETTE HOLDER. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 168 days - an extended review cycle.

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. Standard predicate reliance. 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 Medtec, Inc. devices

Submission Details

510(k) Number K941600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date September 16, 1994
Days to Decision 168 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
61d slower than avg
Panel avg: 107d · This submission: 168d
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 23
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K941600.
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
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
K935397 · Victoreen, Inc. · Dec 1993
FUJIFILM EC-B SERIES CASETTE
K932565 · Fujifilm Medical System U.S.A., Inc. · Jul 1993