FDA.reportPublic FDA data

AISAP Cardio V1.0

Primary DI
G762AISAPCARDIOV10
Brand
AISAP Cardio V1.0
Company
AISAP LTD
Model
2.X.Y.Z
Device description
AISAP CARDIO V1.0 is a software-only medical device that automatically analyzes adult cardiac point-of-care ultrasound (POCUS) images acquired using FDA-cleared ultrasound systems.
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For CancerRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234141000AISAP Cardio V1.0Aisap2024-08-01POK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G762AISAPCARDIOV10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. 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 programs or program packages must be combined with specific hardware or firmware 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
625932941
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
00850012642121Unfold AIAvenda Health, Inc.POK2026-08-19
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
00860012425303RevealAI-LungPrecision Medical Ventures Inc.POK2026-05-29
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360EASPECTS1430e-ASPECTSBRAINOMIX LIMITEDPOK2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
04262352351605DS Core DiagnosisZetta25 AGQIH2026-04-30
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23