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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 a medical device manufactured by Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2017-07-18 under approval 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. It is manufactured by Faxitron Bioptics, LLC. The 510(k) number is K170786.

When was Faxitron Bioptics Speciemen Radiography System approved by the FDA?

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

What company makes Faxitron Bioptics Speciemen Radiography System?

Faxitron Bioptics Speciemen Radiography System is manufactured by Faxitron Bioptics, LLC.

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

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

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING

Other Devices by Faxitron Bioptics, LLC

K153583BioVision Plus K173309Faxitron VisionCT K183142PathVisionXL

Related Devices (Code: MWP)

K153583BioVision PlusFaxitron Bioptics, LLC K173309Faxitron VisionCTFaxitron Bioptics, LLC K192939Volumetric Specimen ImagerClarix Imaging K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc. K183142PathVisionXLFaxitron Bioptics, LLC

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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