INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS


Device Classification Name

system, therapeutic, x-ray

510(k) Number K121653
Device Name INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
Applicant
CARL ZEISS MEDITEC, INC.
5160 hacienda drive
dublin, 
CA 
95030

Applicant Contact sarah harrington
Correspondent
CARL ZEISS MEDITEC, INC.
5160 hacienda drive
dublin, 
CA 
95030

Correspodent Contact sarah harrington
Regulation Number 892.5900
Classification Product Code
JAD  
Date Received 06/05/2012
Decision Date 12/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Clinical Trials NCT00983684
Reviewed by Third Party No

Combination Product

No