DIRECT DIGITIZER, REGIUS MODEL 210

Solid State X-ray Imager (flat Panel/digital Imager)

KONICA MINOLTA MEDICAL & GRAPHIC, INC.

The following data is part of a premarket notification filed by Konica Minolta Medical & Graphic, Inc. with the FDA for Direct Digitizer, Regius Model 210.

Pre-market Notification Details

Device IDK092717
510k NumberK092717
Device Name:DIRECT DIGITIZER, REGIUS MODEL 210
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York,  NY  10017
ContactRussel Munves
CorrespondentRussel Munves
KONICA MINOLTA MEDICAL & GRAPHIC, INC. 140 EAST 45TH ST., 25TH FLOOR TWO GRAND CENTRAL TOWER New York,  NY  10017
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-03
Decision Date2009-10-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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