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FDA 510(k)

Faxitron Bioptics Speciemen Radiography System

K-Number: K170786 · 2017-07-18

ApplicantFaxitron Bioptics, LLC
Decision Date2017-07-18
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Faxitron Bioptics Speciemen Radiography System is the device name listed in this FDA 510(k) record. The listed applicant is Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K170786. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Faxitron Bioptics Speciemen Radiography System?

Faxitron Bioptics Speciemen Radiography System is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K170786.

When did Faxitron Bioptics Speciemen Radiography System receive FDA 510(k) clearance?

Faxitron Bioptics Speciemen Radiography System received FDA 510(k) clearance on 2017-07-18, under 510(k) number K170786.

Who is the listed applicant for Faxitron Bioptics Speciemen Radiography System?

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

What is the FDA product code for Faxitron Bioptics Speciemen Radiography System?

The FDA product code for Faxitron Bioptics Speciemen Radiography System is MWP.

Other records listing Faxitron Bioptics, LLC 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.

K183142PathVisionXLK173309Faxitron VisionCTK153583BioVision Plus

Related Devices (Code: MWP)

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.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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