BSD3543 Digital Flat Panel X-ray Detector
K-Number: K162487 · 2016-10-14
ApplicantBontech, Inc.
Decision Date2016-10-14
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BSD3543 Digital Flat Panel X-ray Detector is a medical device manufactured by Bontech, Inc.. It received FDA 510(k) clearance on 2016-10-14 under approval number K162487. 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 BSD3543 Digital Flat Panel X-ray Detector?
BSD3543 Digital Flat Panel X-ray Detector is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Bontech, Inc.. The 510(k) number is K162487.
When was BSD3543 Digital Flat Panel X-ray Detector approved by the FDA?
BSD3543 Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2016-10-14, under approval number K162487.
What company makes BSD3543 Digital Flat Panel X-ray Detector?
BSD3543 Digital Flat Panel X-ray Detector is manufactured by Bontech, Inc..
What is the FDA product code for BSD3543 Digital Flat Panel X-ray Detector?
The FDA product code for BSD3543 Digital Flat Panel X-ray Detector is MQB.
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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.