SKR 4000

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 4000.

Pre-market Notification Details

Device IDK191645
510k NumberK191645
Device Name:SKR 4000
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Konica Minolta, Inc. 1 Sakura-machi Hino-shi,  JP 191-8511
ContactTsutomu Fukui
CorrespondentRussell D. Munves
Storch Amini PC 140 East 45th Street 25th Floor New York,  NY  10017
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-19
Decision Date2019-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560141947986 K191645 000
04560141948631 K191645 000

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