Lung Image Analysis

GUDID 00811907031819

The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.

PULMONX CORPORATION

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Primary Device ID00811907031819
NIH Device Record Key47da41b8-e68e-4d41-a1f3-680023bc5157
Commercial Distribution StatusIn Commercial Distribution
Brand NameLung Image Analysis
Version Model NumberLIA-01-001
Company DUNS958582595
Company NamePULMONX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com
Phone866-300-4550
EmailUSCustomerService@pulmonx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811907031819 [Primary]

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-13
Device Publish Date2022-09-05

Devices Manufactured by PULMONX CORPORATION

00811907031925 - Chartis Precision Catheter2024-03-25 The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a
00811907031819 - Lung Image Analysis2022-09-13The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
00811907031819 - Lung Image Analysis2022-09-13 The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax
00811907031161 - Pulmonx Chartis Tablet Console2022-03-08 The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for
M776CHRCO100 - Chartis Console2020-08-07 The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify c
00811907030423 - Zephyr Endobronchial Valve2019-09-02 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and t
00811907031222 - Zephyr Delivery Catheter2019-09-02 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and t
M776CHRCA120 - Chartis Catheter2018-11-05 The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a stand
00811907030126 - Zephyr Endobronchial Valve2018-08-20 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and t

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