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FDA 510(k)

Faxitron VisionCT

K-Number: K173309 · 2018-05-09

ApplicantFaxitron Bioptics, LLC
Decision Date2018-05-09
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Faxitron VisionCT is a medical device manufactured by Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2018-05-09 under approval number K173309. 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 VisionCT?

Faxitron VisionCT is a medical device that received FDA 510(k) clearance on 2018-05-09. It is manufactured by Faxitron Bioptics, LLC. The 510(k) number is K173309.

When was Faxitron VisionCT approved by the FDA?

Faxitron VisionCT received FDA 510(k) clearance on 2018-05-09, under approval number K173309.

What company makes Faxitron VisionCT?

Faxitron VisionCT is manufactured by Faxitron Bioptics, LLC.

What is the FDA product code for Faxitron VisionCT?

The FDA product code for Faxitron VisionCT is MWP.

Other Devices by Faxitron Bioptics, LLC

K153583BioVision Plus K170786Faxitron Bioptics Speciemen Radiography System K183142PathVisionXL

Related Devices (Code: MWP)

K153583BioVision PlusFaxitron Bioptics, LLC K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron 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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