AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION


Device Classification Name

system, tomography, computed, emission

510(k) Number K992317
Device Name AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
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 07/09/1999
Decision Date 10/01/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No