APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4


Device Classification Name

system, tomography, computed, emission

510(k) Number K033001
Device Name APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
Applicant
TRANSPHOTON CORPORATION
37 electric avenue
lunenburg, 
MA 
01462

Applicant Contact scott jennings
Correspondent
TRANSPHOTON CORPORATION
37 electric avenue
lunenburg, 
MA 
01462

Correspodent Contact scott jennings
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 09/25/2003
Decision Date 12/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No