Cleared Traditional

GENESIS

K122768 · Dornier Medtech America, Inc. · Radiology
Jan 2013
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K122768 is an FDA 510(k) clearance for the GENESIS, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Dornier Medtech America, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on January 18, 2013, 130 days after receiving the submission on September 10, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K122768 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2012
Decision Date January 18, 2013
Days to Decision 130 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAA — System, X-ray, Fluoroscopic, Image-intensified
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1650

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