Cleared Traditional

K921826 - KODAK INSIGHT PORTABLE IMAGING SYSTEM

K921826 is an FDA 510(k) clearance for KODAK INSIGHT PORTABLE IMAGING SYSTEM, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K921826 · Eastman Kodak Company · Radiology device
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Aug 1992
Decision
132d
Days
Class 2
Risk

K921826 is an FDA 510(k) clearance for the KODAK INSIGHT PORTABLE IMAGING SYSTEM. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 132 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K921826

510(k) Number K921826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1992
Decision Date August 26, 1992
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
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 K921826.
FUJIFILM EC-B SERIES CASETTE
K932565 · Fujifilm Medical System U.S.A., Inc. · Jul 1993
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · Cook, Inc. · Jan 1993
DU PONT MAMMOGRAPHY CASSETTE
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