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LungVision Tool

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K172955

by Bodyvision Medical , Ltd.

Identifiers

510(k) Number
K172955 FDA 510(k)
FDA Product Code
EOQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4680 FDA 510(k)
Regulation Number
874.4680 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LungVision Tool is a working channel device designed for use within the respiratory system. It serves as an interface to guide endotherapy accessories or ultrasound probes during bronchoscopic procedures, facilitating precise navigation to target areas in the lungs.

This device is intended for single-use and is compatible with standard bronchoscopes and Olympus Bronchoscope BF-1TH190. It is supplied sterile and is regulated under FDA 510K clearance (K172955) and MDR authorisation. The product code assigned is EOQ, categorised under the Ear, Nose, and Throat advisory committee classification.

Frequently asked questions

What types of bronchoscopes is the LungVision Tool compatible with, and how does it enhance bronchoscopic procedures?

The LungVision Tool is designed to work with standard bronchoscopes as well as the Olympus Bronchoscope BF-1TH190. It serves as a working channel interface to guide endotherapy accessories or ultrasound probes, enabling more precise navigation and access to target areas within the respiratory system during bronchoscopic procedures.

Is the LungVision Tool intended for reuse, or is it meant to be used only once? How does this affect its use in clinical settings?

The LungVision Tool is explicitly intended for single-use only, which helps minimize infection risks and ensures consistent performance. This makes it ideal for clinical settings where sterility and patient safety are critical priorities, as each procedure requires a new device.

How is the LungVision Tool supplied, and what does the sterility guarantee mean for clinicians?

The LungVision Tool is supplied sterile, meaning it is pre-packaged and ready for immediate use without additional sterilization. This ensures clinicians can rely on a clean, uncontaminated device right out of the packaging, reducing preparation time and potential exposure risks.

What regulatory pathways does the LungVision Tool follow, and how does this impact its availability in different markets?

The LungVision Tool has undergone FDA 510(k) clearance (K172955) and MDR authorization, confirming its compliance with U.S. and European Union regulatory standards. This dual approval streamlines its availability in both markets, ensuring clinicians can access it with confidence in regions governed by these frameworks.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Body Vision Medical | AI-Powered Lung Cancer Diagnosis, BODY VISION MEDICAL LTD LV2055011 LungVision Tool - RevMed, LungVision - Physician AI Tools

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bodyvision Medical , Ltd.

Sources (2)

  • FDA 510(k) K172955 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026