Cleared Traditional

KODAK DIRECTVIEW DR SYSTEM DETECTOR

K051483 · Eastman Kodak Company · Radiology
Jun 2005
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K051483 is an FDA 510(k) clearance for the KODAK DIRECTVIEW DR SYSTEM DETECTOR, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on June 21, 2005, 15 days after receiving the submission on June 6, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K051483 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2005
Decision Date June 21, 2005
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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