Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioVision Plus

K-Number: K153583 · 2016-04-01

ApplicantFaxitron Bioptics, LLC
Decision Date2016-04-01
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BioVision Plus 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 2016-04-01 under 510(k) number K153583. 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 BioVision Plus?

BioVision Plus is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Faxitron Bioptics, LLC. The 510(k) number is K153583.

When did BioVision Plus receive FDA 510(k) clearance?

BioVision Plus received FDA 510(k) clearance on 2016-04-01, under 510(k) number K153583.

Who is the listed applicant for BioVision Plus?

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 BioVision Plus?

The FDA product code for BioVision Plus 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 VisionCTK170786Faxitron Bioptics Speciemen Radiography System

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

View on FDA Database →

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

↑