Cleared Traditional

GENESIS II

K133434 · Dornier Medtech America, Inc. · Radiology
Nov 2014
Decision
383d
Days
Class 2
Risk

About This 510(k) Submission

K133434 is an FDA 510(k) clearance for the GENESIS II, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on November 26, 2014, 383 days after receiving the submission on November 8, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K133434 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2013
Decision Date November 26, 2014
Days to Decision 383 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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