Fibresolve

Primary DI
G86331
Brand
Fibresolve
Company
IMVARIA INC.
Model
2.0
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWORadiology Software For Referral Of Findings Related To Fibrotic Lung Disease.Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G86331PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
117159593
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G86321ScreenDx1.02026-04-23
G86311Fibresolve1.02026-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850894007919IQ-UIP4DMEDICAL LIMITEDQWO2026-05-10
G86321ScreenDxIMVARIA INC.QWO2026-04-23
G86311FibresolveIMVARIA INC.QWO2026-04-22