Cleared Traditional

CYPHER DICOM PRINT SOLUTION

K092280 · Virtual Imaging, Inc. · Radiology
Oct 2009
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K092280 is an FDA 510(k) clearance for the CYPHER DICOM PRINT SOLUTION, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Virtual Imaging, Inc. (Deerfield, US). The FDA issued a Cleared decision on October 16, 2009, 80 days after receiving the submission on July 28, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K092280 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 2009
Decision Date October 16, 2009
Days to Decision 80 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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