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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 the device name listed in this FDA 510(k) record. The listed applicant is Faxitron Bioptics, LLC. It received FDA 510(k) clearance on 2018-05-09 under 510(k) 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. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K173309.

When did Faxitron VisionCT receive FDA 510(k) clearance?

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

Who is the listed applicant for Faxitron VisionCT?

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 VisionCT?

The FDA product code for Faxitron VisionCT 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.

K183142PathVisionXLK170786Faxitron Bioptics Speciemen Radiography SystemK153583BioVision 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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