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FDA 510(k)

PathVisionXL

K-Number: K183142 · 2019-03-14

ApplicantFaxitron Bioptics, LLC
Decision Date2019-03-14
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PathVisionXL is a medical device manufactured by Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2019-03-14 under approval number K183142. 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 PathVisionXL?

PathVisionXL is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Faxitron Bioptics, LLC. The 510(k) number is K183142.

When was PathVisionXL approved by the FDA?

PathVisionXL received FDA 510(k) clearance on 2019-03-14, under approval number K183142.

What company makes PathVisionXL?

PathVisionXL is manufactured by Faxitron Bioptics, LLC.

What is the FDA product code for PathVisionXL?

The FDA product code for PathVisionXL is MWP.

Other Devices by Faxitron Bioptics, LLC

K153583BioVision Plus K170786Faxitron Bioptics Speciemen Radiography System K173309Faxitron VisionCT

Related Devices (Code: MWP)

K153583BioVision PlusFaxitron Bioptics, LLC K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC K173309Faxitron VisionCTFaxitron Bioptics, LLC K192939Volumetric Specimen ImagerClarix Imaging K193317CoreLite X-Ray Specimen CabinetCirdan Imaging Limited K183624Kubtec Mozart (Xpert42)Kub Technologies, 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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