Cleared Traditional

K862944 - KODAK CFT FILM SO-141

K862944 is the FDA 510(k) clearance for KODAK CFT FILM SO-141 by Eastman Kodak Company. It is a Class 1 Radiology device (product code IWZ) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K862944 · Eastman Kodak Company · Radiology device
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Aug 1986
Decision
7d
Days
Class 1
Risk

K862944 is an FDA 510(k) clearance for the KODAK CFT FILM SO-141. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on August 12, 1986 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K862944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date August 12, 1986
Days to Decision 7 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 107d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWZ Film, Radiographic

All 20
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K862944.
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K813005 · Eastman Kodak Company · Nov 1981