Cleared Traditional

K893728 - PINK CASSETTE CADDIE

K893728 is an FDA 510(k) clearance for PINK CASSETTE CADDIE, manufactured by Medical Technique Instruments, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K893728 · Medical Technique Instruments, Inc. · Radiology device
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Sep 1989
Decision
124d
Days
Class 2
Risk

K893728 is an FDA 510(k) clearance for the PINK CASSETTE CADDIE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Medical Technique Instruments, Inc. (Kirkland, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 124 days - within the typical 510(k) review window.

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 Medical Technique Instruments, Inc. devices

FDA 510(k) Submission Details - K893728

510(k) Number K893728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1989
Decision Date September 18, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 107d · This submission: 124d
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 36
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K893728.
KODAK INSIGHT PORTABLE IMAGING SYSTEM
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K900620 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK X-OMATIC RA CASSETTE
K890750 · Eastman Kodak Company · Mar 1989
KODAK MIN-R 2 CASSETTE
K890361 · Eastman Kodak Company · Feb 1989
KODAFLEX II RADIATION THERAPY L CASSETTE
K885178 · Eastman Kodak Company · Feb 1989