Cleared Traditional

CARESTREAM DRYVIEW 5850 LASER IMAGER

K090469 · Carestream Health, Inc. · Radiology
May 2009
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K090469 is an FDA 510(k) clearance for the CARESTREAM DRYVIEW 5850 LASER IMAGER, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Carestream Health, Inc. (Oakdale, US). The FDA issued a Cleared decision on May 22, 2009, 88 days after receiving the submission on February 23, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K090469 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2009
Decision Date May 22, 2009
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LMC — Camera, Multi Format, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2040

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