Cleared Traditional

VANTAGE MODEL V5000, V5100, V5000C, V5100C

K122643 · Midmark Corp. · Radiology
Jan 2013
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K122643 is an FDA 510(k) clearance for the VANTAGE MODEL V5000, V5100, V5000C, V5100C, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Midmark Corp. (Lincolnshire, US). The FDA issued a Cleared decision on January 7, 2013, 131 days after receiving the submission on August 29, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K122643 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2012
Decision Date January 07, 2013
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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