KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K112132
Device Name KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
Applicant
MEDICATECH USA
8870 ravello court
naples, 
FL 
34114

Applicant Contact daniel kamm
Correspondent
MEDICATECH USA
8870 ravello court
naples, 
FL 
34114

Correspodent Contact daniel kamm
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 07/26/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No