CT:VQ

Primary DI
01935687000038
Brand
CT:VQ
Company
4DMEDICAL LIMITED
Model
2.2.0
Device description
CT:VQ software is a non-invasive image post-processing technology, using CT lung images to provide clinical decisionsupport for thoracic disease diagnosis and management in adult patients. It utilizes two non-contrast chest CT studies toquantify and visualize ventilation and perfusion.Quantification and visualizations are provided as DICOM images. CT:VQ may be used when Radiologists,Pulmonologists, and/or Nuclear Medicine Physicians need a better understanding of a patient's lung function and/orrespiratory condition.
Published
2025-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251484000CT:VQ4Dmedical Limited2025-08-28JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01935687000038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01935687000038019356870000381935687000038

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

Regulatory Flags#

DUNS number
747517097
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850894007919IQ-UIP2.0.02026-05-10
19356870000038CT:VQ2.2.02026-01-28
19356870000021CT LVAS1.x2024-06-20
19356870000014XV Lung Ventilation Analysis SoftwareXV LVAS2021-01-18

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