BSD3543 Digital Flat Panel X-ray Detector

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

BONTECH INC.

The following data is part of a premarket notification filed by Bontech Inc. with the FDA for Bsd3543 Digital Flat Panel X-ray Detector.

Pre-market Notification Details

Device IDK162487
510k NumberK162487
Device Name:BSD3543 Digital Flat Panel X-ray Detector
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant BONTECH INC. YOUNGTONG-GU YOUNGTONG-DONG 980-3, DIGITAL EMPIRE D #1201 Suwon-si,  KR 443-702
ContactKwang S. Choi
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-07
Decision Date2016-10-14
Summary:summary

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