VANTAGE 2.5


Device Classification Name

system, tomography, computed, emission

510(k) Number K991607
Device Name VANTAGE 2.5
Applicant
ADAC LABORATORIES
540 alder dr.
milpitas, 
CA 
95035

Applicant Contact dennis w henkelman
Correspondent
ADAC LABORATORIES
540 alder dr.
milpitas, 
CA 
95035

Correspodent Contact dennis w henkelman
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 05/10/1999
Decision Date 07/26/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No