Cleared Traditional

DRYVIEW CHROMA IMAGING SYSTEM

K111566 · Carestream Health, Inc. · Radiology
Oct 2011
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K111566 is an FDA 510(k) clearance for the DRYVIEW CHROMA IMAGING SYSTEM, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on October 6, 2011, 122 days after receiving the submission on June 6, 2011. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K111566 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2011
Decision Date October 06, 2011
Days to Decision 122 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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