SKR 3000

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

Konica Minolta, Inc.

The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Skr 3000.

Pre-market Notification Details

Device IDK210619
510k NumberK210619
Device Name:SKR 3000
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Konica Minolta, Inc. 1 Sakura-machi Hino-shi,  JP 191-8511
ContactTsutomu Fukui
CorrespondentJan Maniscalco
Konica Minolta Healthcare Americas, Inc. 2217 US Highway 70 E Garner,  NC  27529
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560141945852 K210619 000
04560141945814 K210619 000
04560141945807 K210619 000
04560141945784 K210619 000

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