Cleared Special

GENESIS

K151485 · Dornier Medtech America, Inc. · Radiology
Jun 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K151485 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. (Kennesaw, US). The FDA issued a Cleared decision on June 30, 2015, 28 days after receiving the submission on June 2, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number K151485 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2015
Decision Date June 30, 2015
Days to Decision 28 days
Submission Type Special
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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