SUNIRAY 5.2


Device Classification Name

system, image processing, radiological

510(k) Number K072665
Device Name SUNIRAY 5.2
Applicant
ORANGEDENTAL GMBH & CO. KG
im forstgarten 11
biberach, 

DE

88400

Applicant Contact marc fieber
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/21/2007
Decision Date 10/03/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No