BSD4343R Digital Flat Panel X-ray Detector
K-Number: K171485 · 2017-06-21
ApplicantBontech, Inc.
Decision Date2017-06-21
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BSD4343R Digital Flat Panel X-ray Detector is a medical device manufactured by Bontech, Inc.. It received FDA 510(k) clearance on 2017-06-21 under approval number K171485. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BSD4343R Digital Flat Panel X-ray Detector?
BSD4343R Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Bontech, Inc.. The 510(k) number is K171485.
When was BSD4343R Digital Flat Panel X-ray Detector approved by the FDA?
BSD4343R Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2017-06-21, under approval number K171485.
What company makes BSD4343R Digital Flat Panel X-ray Detector?
BSD4343R Digital Flat Panel X-ray Detector is manufactured by Bontech, Inc..
What is the FDA product code for BSD4343R Digital Flat Panel X-ray Detector?
The FDA product code for BSD4343R Digital Flat Panel X-ray Detector is MQB.
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K163019CareView 750Cw/750C X-ray Flat Panel DetectorsCareray Digital Medical System Co., Ltd.
K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.