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 IDK223267
510k NumberK223267
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. 411 Newark Pompton Turnpike Wayne,  NJ  07470
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-10-24
Decision Date2022-11-17

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