FRAXION

Accelerator, Linear, Medical

MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH

The following data is part of a premarket notification filed by Medical Intelligence Medizintechnik Gmbh with the FDA for Fraxion.

Pre-market Notification Details

• Device ID: K112210
• 510k Number: K112210
• Device Name: FRAXION
• Classification: Accelerator, Linear, Medical
• Applicant: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ROBERT-BOSCH-STRASSE 8 Schwabmunchen, DE 86830
• Contact: Michael Wolff
• Correspondent: Michael Wolff; MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH ROBERT-BOSCH-STRASSE 8 Schwabmunchen, DE 86830
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-08-01
• Decision Date: 2011-11-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056719002084	K112210	000
04056719001506	K112210	000
04056719001490	K112210	000
04056719001483	K112210	000
04056719001476	K112210	000
04056719001469	K112210	000
04056719001452	K112210	000
04056719001445	K112210	000
04056719001438	K112210	000
04056719001421	K112210	000
04056719001414	K112210	000
04056719001407	K112210	000
04056719001391	K112210	000
04056719001384	K112210	000
04056719001377	K112210	000
04056719001513	K112210	000
04056719001520	K112210	000
04056719001537	K112210	000
04056719002077	K112210	000
04056719002060	K112210	000
04056719001797	K112210	000
04056719001612	K112210	000
04056719001605	K112210	000
04056719001766	K112210	000
04056719001759	K112210	000
04056719001650	K112210	000
04056719001643	K112210	000
04056719001636	K112210	000
04056719001575	K112210	000
04056719001568	K112210	000
04056719001551	K112210	000
04056719001544	K112210	000
04056719001360	K112210	000