Cleared Special

KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE

K021903 · Eastman Kodak Company · Radiology
Jul 2002
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K021903 is an FDA 510(k) clearance for the KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE, 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 July 10, 2002, 30 days after receiving the submission on June 10, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1850.

Submission Details

510(k) Number K021903 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2002
Decision Date July 10, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

Device Classification

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

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