AI-CVD

Primary DI
00860016420922
Brand
AI-CVD
Company
Heart Lung Corporation
Model
V0.3.0
Device description
AI-CVD is an opportunistic AI-powered quantitative imaging software tool that provides automated CT-derived anatomical and density-based measurements for clinician review. AI-CVD has a modular structure that provides quantitative measurements including coronary artery calcium score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chamber volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle and fat composition. AI-CVD is intended for use with non-contrast and contrast-enhanced CT scans of the chest, abdomen, and pelvis as applicable. The device does not provide diagnostic interpretation or risk prediction. Measurements are intended to be reviewed by radiologists or other medical professionals and used in conjunction with clinical evaluation.
Published
2026-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGIDensitometer, Bone
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGIDensitometer, BoneRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860016420922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860016420922008600164209228600164209220860016420922

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Contacts#

Phone, Email table
PhoneEmail
310-510-6004contact@heartlung.ai

Regulatory Flags#

DUNS number
053322346
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860016420908AutoBMDV2.2.32026-09-04

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Primary DI, Brand, Company table
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