Address:125 Nicholson Ln,San Jose,CA,95134,US
Device Description : Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : A collection of sterile devices designed to access and perform a biopsy sample d A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : Archimedes software is installed on a desktop computer used to plan procedures a Archimedes software is installed on a desktop computer used to plan procedures and navigate to targets in the lung. The Procedure Module offers real-time navigation guidance for use during the bronchoscopy procedure. The Software provides the option to segment previously acquired CT or other DICOM data sets and overlay and register these segmented data sets onto live fluoroscopic X-ray images. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile single use flexible tube that provides a working channel during a bron A sterile single use flexible tube that provides a working channel during a bronchoscopic procedure through which other devices may be introduced to the targeted area within the respiratory organs. The sheath is advanced through the working channel of a bronchoscope and allows for the repeated placement of endoscopic devices to a specified lesion(s) during a procedure.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile single use flexible tube with a balloon at or near the distal tip that A sterile single use flexible tube with a balloon at or near the distal tip that is inserted through the bronchoscope or sheath and used to dilate the target lung tissue of the bronchial tree.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths on the computer or printed plan to the region of interest through both airways and lung tissue.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : LungPoint Planning Software is software installed on a laptop computer used for LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : LungPoint VBN Software is software installed on a desktop computer used to plan LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : Single use coring needle for retrieval of tissue samples. It is placed through Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes
Device Description : Archimedes Planning Software is software installed on a laptop computer used for Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
Device Class : 2
Duns Number: 078684808
Premarket Exempt : No
Prescription Use : Yes