STEREOTACTIC BODY FRAME


Device Classification Name

accelerator, linear, medical

510(k) Number K960338
Device Name STEREOTACTIC BODY FRAME
Applicant
ELEKTA INSTRUMENT AB
181 40 smokesignal dr.
san diego, 
CA 
92127

Applicant Contact carol patterson
Correspondent
ELEKTA INSTRUMENT AB
181 40 smokesignal dr.
san diego, 
CA 
92127

Correspodent Contact carol patterson
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 01/24/1996
Decision Date 04/23/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No