BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST


Device Classification Name

accelerator, linear, medical

510(k) Number K081218
Device Name BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
Applicant
IT-V MEDIZINTECHNIK, GMBH
56 westcott road
stamford, 
CT 
06902

Applicant Contact cornelia damsky
Correspondent
IT-V MEDIZINTECHNIK, GMBH
56 westcott road
stamford, 
CT 
06902

Correspodent Contact cornelia damsky
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 04/30/2008
Decision Date 07/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No