BODYFIX SYSTEM

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 Bodyfix System.

Pre-market Notification Details

• Device ID: K121530
• 510k Number: K121530
• Device Name: BODYFIX SYSTEM
• Classification: Accelerator, Linear, Medical
• Applicant: MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH Robert-Bosch-Strasse 8 Schwabmuenchen, DE 86830
• Contact: Michael Wolff
• Correspondent: Michael Wolff; MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH Robert-Bosch-Strasse 8 Schwabmuenchen, 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: 2012-05-24
• Decision Date: 2012-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04056719000646	K121530	000
04056719000219	K121530	000
04056719000226	K121530	000
04056719000233	K121530	000
04056719000240	K121530	000
04056719000257	K121530	000
04056719000271	K121530	000
04056719000288	K121530	000
04056719000318	K121530	000
04056719000332	K121530	000
04056719000455	K121530	000
04056719000462	K121530	000
04056719000479	K121530	000
04056719000486	K121530	000
04056719000493	K121530	000
04056719000509	K121530	000
04056719000516	K121530	000
04056719000196	K121530	000
04056719000189	K121530	000
04056719000011	K121530	000
04056719000028	K121530	000
04056719000035	K121530	000
04056719000059	K121530	000
04056719000066	K121530	000
04056719000073	K121530	000
04056719000080	K121530	000
04056719000097	K121530	000
04056719000103	K121530	000
04056719000110	K121530	000
04056719000127	K121530	000
04056719000134	K121530	000
04056719000141	K121530	000
04056719000158	K121530	000
04056719000165	K121530	000
04056719000172	K121530	000
04056719000523	K121530	000
04056719000530	K121530	000
04056719000813	K121530	000
04056719000820	K121530	000
04056719000837	K121530	000
04056719000844	K121530	000
04056719000851	K121530	000
04056719000868	K121530	000
04056719000875	K121530	000
04056719000882	K121530	000
04056719000899	K121530	000
04056719000905	K121530	000
04056719000912	K121530	000
04056719000929	K121530	000
04056719000936	K121530	000
04056719000264	K121530	000
04056719000295	K121530	000
04056719001933	K121530	000
04056719000806	K121530	000
04056719000790	K121530	000
04056719000547	K121530	000
04056719000554	K121530	000
04056719000561	K121530	000
04056719000578	K121530	000
04056719000585	K121530	000
04056719000592	K121530	000
04056719000608	K121530	000
04056719000615	K121530	000
04056719000622	K121530	000
04056719000691	K121530	000
04056719000707	K121530	000
04056719000714	K121530	000
04056719000738	K121530	000
04056719000769	K121530	000
04056719000776	K121530	000
04056719000783	K121530	000
04056719001940	K121530	000