GENESIS

System, X-ray, Fluoroscopic, Image-intensified

DORNIER MEDTECH AMERICA, INC.

The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Genesis.

Pre-market Notification Details

• Device ID: K122768
• 510k Number: K122768
• Device Name: GENESIS
• Classification: System, X-ray, Fluoroscopic, Image-intensified
• Applicant: DORNIER MEDTECH AMERICA, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004
• Contact: John J Smith
• Correspondent: John J Smith; DORNIER MEDTECH AMERICA, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004
• Product Code: JAA
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-10
• Decision Date: 2013-01-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049957005566	K122768	000
04049957005559	K122768	000
04049957004231	K122768	000
04049957004224	K122768	000
04049957004118	K122768	000
04049957004095	K122768	000