Cleared Traditional

KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253

K040378 · Eastman Kodak Company · Radiology
May 2004
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K040378 is an FDA 510(k) clearance for the KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253, a Cassette, Radiographic Film (Class II — Special Controls, product code IXA), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on May 24, 2004, 97 days after receiving the submission on February 17, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number K040378 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2004
Decision Date May 24, 2004
Days to Decision 97 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXA — Cassette, Radiographic Film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1850

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