Cleared Traditional

K941600 - MT-300 CASSETTE HOLDER

K941600 is an FDA 510(k) clearance for MT-300 CASSETTE HOLDER, manufactured by Medtec, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K941600

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.

IXA Device Classification - Class 2, Special Controls

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 34
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K941600.
RADIOGRAPHIC FILM CASSETTES
K962336 · Unidex Group, Inc. · 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
CRONEX REGULAR CASSETTE
K941475 · Dupont Medical Products · Jul 1994
DUPONT CRONEX PORTABLE GRID CASSETTE
K941518 · Dupont Medical Products · Jun 1994