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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bontech, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) 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. The listed applicant is Bontech, Inc.. The 510(k) number is K162487.

When did BSD3543 Digital Flat Panel X-ray Detector receive FDA 510(k) clearance?

BSD3543 Digital Flat Panel X-ray Detector received FDA 510(k) clearance on 2016-10-14, under 510(k) number K162487.

Who is the listed applicant for BSD3543 Digital Flat Panel X-ray Detector?

The FDA 510(k) record lists Bontech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

Other records listing Bontech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243864BONX805K200787BSD3543WK171485BSD4343R Digital Flat Panel X-ray DetectorK160204BSD4343 Digital Flat Panel X-ray Detector

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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.

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