ALPHARD CONE BEAM CT, MODEL X178


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K072574
Device Name ALPHARD CONE BEAM CT, MODEL X178
Applicant
TAKARA BELMONT CORP.
po box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
TAKARA BELMONT CORP.
po box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 09/13/2007
Decision Date 10/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No