IB NEURO, VERSION 1.0


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K080762
Device Name IB NEURO, VERSION 1.0
Applicant
IMAGING BIOMETRICS, LLC
1035 katherine dr.
elm grove, 
WI 
53122

Applicant Contact michael schmainda
Correspondent
IMAGING BIOMETRICS, LLC
1035 katherine dr.
elm grove, 
WI 
53122

Correspodent Contact michael schmainda
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 03/18/2008
Decision Date 05/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No