KONICA DIRECT DIGITIZER REGIUS, MODEL 170


Device Classification Name

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

510(k) Number K023061
Device Name KONICA DIRECT DIGITIZER REGIUS, MODEL 170
Original Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
2970 ishikawa-cho
hachioji-shi tokyo, 

JP

192-8505

Original Contact koji kubo
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 09/16/2002
Decision Date 10/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No