Cleared Traditional

KODAK CINEFLUOROGRAPHIC FILM SO-274 (K813005) - FDA 510(k) Clearance

Class I Radiology device.

K813005 · Eastman Kodak Company · Radiology device
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Nov 1981
Decision
28d
Days
Class 1
Risk

K813005 is an FDA 510(k) clearance for the KODAK CINEFLUOROGRAPHIC FILM SO-274. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Eastman Kodak Company (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 28 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 K813005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1981
Decision Date November 24, 1981
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 18
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K813005.
KODAK CFT FILM SO-141
K862944 · Eastman Kodak Company · Aug 1986
KODAK T-MAT L FILM SO-387
K833234 · Eastman Kodak Company · Oct 1983
CRONEX LO-DOSE MAMMOGRAPHY
K832504 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
KODAK ORTHO L FILM
K802171 · Eastman Kodak Company · Oct 1980
KODAK EKTASPEED DENTAL X-RAY FILM
K800901 · Eastman Kodak Company · May 1980
KODAK CFN FILM SO-224
K792178 · Eastman Kodak Company · Jan 1980