FAXITRON SPECIEN RADIOGRAPHY SYSTEM


Device Classification Name

cabinet,x-ray system

510(k) Number K122428
Device Name FAXITRON SPECIEN RADIOGRAPHY SYSTEM
Applicant
FAXITRON BIOPTICS LLC
3440 e. britannia drive
suite 150
tucson, 
AZ 
85706

Applicant Contact douglas c wiegman
Correspondent
FAXITRON BIOPTICS LLC
3440 e. britannia drive
suite 150
tucson, 
AZ 
85706

Correspodent Contact douglas c wiegman
Regulation Number 892.1680
Classification Product Code
MWP  
Date Received 08/09/2012
Decision Date 09/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No