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510(k) Data Aggregation
K Number
K183593Device Name
Lung Vision System
Manufacturer
Body Vision Medical Ltd.
Date Cleared
2019-04-18
(118 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Body Vision Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Device Description
The Lung Vision System (K163622) is designed to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor. Lung Vision system includes a main unit and a tablet vs. the previous PC based hardware platform. Image processing algorithms are executed on the main unit and the tablet is used as a primary method of interacting with the system. The Tablet is for planning but is not for diagnostic purposes. Both can perform the following functions: segment previously acquired DICOM 3D CT image data, register DICOM 3D CT image data with live fluoroscopic X-ray image, overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, obtained on a Fluoroscopic system.
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K Number
K172955Device Name
LungVision Tool
Manufacturer
Body Vision Medical Ltd.
Date Cleared
2018-04-26
(212 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Body Vision Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endotherapy accessories and ultrasound probe to guide the endotherapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
Device Description
Lung Vision Tool is an instrument designed as a working channel intended to be used with standard bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasound probe to the target area, specifically within the respiratory system.
LungVision tool is designed to be used by pulmonologists or thoracic surgeons during pulmonary procedures.
The LungVision Tool is designed to be connected to a standard Bronchoscope Instrument Port.
The Lung Vision Bronchoscope Adaptor is used to connect the LungVision Handle to the Bronchoscope instrument port / working channel entrance, and to allow the physician to release the tool from the bronchoscope. The current adaptor is for the Olympus Bronchoscope Model BF-1T160.
More types of Bronchoscope Adaptors for other bronchoscopy brands and models.
Lung Vision Tool Sheath can accommodate endo-therapy accessories and ultrasound probes with an outer diameter up to 1.9 mm.
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K Number
K163622Device Name
Lung Vision
Manufacturer
BODY VISION MEDICAL LTD.
Date Cleared
2017-05-11
(140 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BODY VISION MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lung Vision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Device Description
The LungVision System is designed enabling users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
The Lung Vision System is designed to assist the physician in guiding endobronchial tools towards the target area of interest inside the patient lungs. Prior to the endoscopic procedure the system allows planning the target location and the path to the target area on the CT scan. During the endoscopic procedure the system overlays planned data over fluoroscopic images to support endobronchial tool navigation towards the area of interest. The system does not include the Fluoroscope, Bronchoscope or the external monitor.
Lung Vision image processing algorithms are executed on a PC based hardware platform, which can perform the following functions:
- segment previously acquired DICOM 3D CT image data, .
- register DICOM 3D CT image data with live fluoroscopic X-ray image
- overlay the segmented 3D CT dataset over a live fluoroscopic X-ray image of the same anatomy, ● obtained on a Fluoroscopic system.
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