Cleared Special

KODAK DIRECTVIEW TABLETOP CASSETTE

K013686 · Eastman Kodak Company · Radiology
Dec 2001
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K013686 is an FDA 510(k) clearance for the KODAK DIRECTVIEW TABLETOP CASSETTE, 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 December 7, 2001, 30 days after receiving the submission on November 7, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number K013686 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2001
Decision Date December 07, 2001
Days to Decision 30 days
Submission Type Special
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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