FDA.report

510(k) K234141

Device
AISAP Cardio V1.0
Applicant
Aisap
510(k) number
K234141
Product code
POK
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-01
Date received
2023-12-29
Regulation
892.2060
Classification name
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Robert Klempfner
Address
The Heart Center, Sheba Medical Center Tel Hashomer Ramat Gan IL 52621 52621

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTD2026-02-18

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