DIGITAL X-RAY IMAGING SYSTEM


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K111103
Device Name DIGITAL X-RAY IMAGING SYSTEM
Applicant
RF CO., LTD
6-5-3 beaune honkomagome 2f
honkomagome
bunkyo-ku, tokyo, 

JP

113-0021

Applicant Contact koji kubo
Correspondent
RF CO., LTD
6-5-3 beaune honkomagome 2f
honkomagome
bunkyo-ku, tokyo, 

JP

113-0021

Correspodent Contact koji kubo
Regulation Number 872.1800
Classification Product Code
MUH  
Subsequent Product Codes
EHD   MQB  
Date Received 04/20/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No