FRAXION


Device Classification Name

accelerator, linear, medical

510(k) Number K112210
Device Name FRAXION
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
robert-bosch-strasse 8
schwabmunchen, 

DE

86830

Applicant Contact michael wolff
Correspondent
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
robert-bosch-strasse 8
schwabmunchen, 

DE

86830

Correspodent Contact michael wolff
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/01/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No