INTRABEAM SYSTEM


Device Classification Name

system, therapeutic, x-ray

510(k) Number K051055
Device Name INTRABEAM SYSTEM
Applicant
CARL ZEISS SURGICAL GMBH
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
CARL ZEISS SURGICAL GMBH
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 892.5900
Classification Product Code
JAD  
Date Received 04/26/2005
Decision Date 05/23/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls