BSD4343R Digital Flat Panel X-ray Detector— 510(k) K171485

Name: FDA 510(k) clearance K171485
Creator: U.S. Food and Drug Administration
Published: 2017-06-21

Substantially Equivalent

Bontech, Inc.

FDA 510(k) clearance K171485 for BSD4343R Digital Flat Panel X-ray Detector, Substantially Equivalent on 2017-06-21. Applicant: Bontech, Inc.. Device class: 2.

Clearance details

Applicant: Bontech, Inc.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2017-05-22
Decision date: 2017-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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