BELLYBOARD, SBRT ACCESSORIES


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K121545
Device Name BELLYBOARD, SBRT ACCESSORIES
Applicant
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
1401 8th street se
orange city, 
IA 
51041

Applicant Contact amanda stahle
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Code
IYE  
Date Received 05/25/2012
Decision Date 06/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls