Lung Image Analysis

Primary DI
00811907031819
Brand
Lung Image Analysis
Company
PULMONX CORPORATION
Model
LIA-01-001
Device description
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.
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811907031819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811907031819008119070318198119070318190811907031819

GMDN Terms#

Term, Definition table
TermDefinition
CT system application softwareAn application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-300-4550USCustomerService@pulmonx.com

Regulatory Flags#

DUNS number
958582595
Device count
1
Lot or batch
true

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00811907030225Zephyr Endobronchial ValveEBV-TS-4.0-LP2018-07-20
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00811907030522Zephyr Delivery CatheterEDC-TS-4.02018-07-20
00811907030621Zephyr Delivery CatheterEDC-TS-4.0-J2018-07-20
00811907030720Zephyr Delivery CatheterEDC-TS-5.52018-07-20
M776CHRCA120Chartis CatheterG3CHR-CA-12.02016-03-25

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