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 IDK182688
510k NumberK182688
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
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-26
Decision Date2018-12-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.