DRAD-3000E, RADREX-I


Device Classification Name

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

510(k) Number K073165
Device Name DRAD-3000E, RADREX-I
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 11/09/2007
Decision Date 11/16/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls