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510(k) K240612

Device
CINA-VCF
Applicant
Avicenna.Ai
510(k) number
K240612
Product code
QFM
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-31
Date received
2024-03-05
Regulation
892.2080
Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Stephane Berger
Address
Zi Athelia, 297 Av. Du Mistral Bât. A, La Ciotat FR 13600 13600

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K233108VinDr-MammoVinbigdata Joint Stock Company2024-05-23
K232410SmartChestMilvue2024-05-10
K231871Radify TriageEnvisionit Deepai, Ltd.2024-01-17
K223754BraveCXBering, Ltd.2023-11-09
K230899qXR-PTX-PEQure.Ai Technologies2023-08-22
K230074Rapid Aneurysm Triage and NotificationIschemaview, Inc.2023-07-27
K222268Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty , Ltd.2023-03-28
K222179Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty , Ltd.2023-03-28
K223443Viz AAAViz. Ai, Inc.2023-03-17