Infervision US Inc

Address:1900 Market St,Philadelphia,PA,19103,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lung Computed Tomography System, Computer-Aided Detection (OEB) (1) Radiological Computer-Assisted Triage And Notification Software (QAS) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

InferRead Lung CT.AI 2.1.2.1 - 00850003095004 Catalog Number :

Device Description : Computer assisted reading tools designed to aid the radiologist in the detection Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.

Device Class : 2

Duns Number: 117164757

Premarket Exempt : No

Product Code : OEB, LLZ

Prescription Use : Yes

Device Count : 1

InferRead CT Stroke.AI - 00850003095011 Catalog Number :

Device Description : InferRead CT Stroke.AI is a radiological computer aided triage and notification InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).

Device Class : 2

Duns Number: 117164757

Premarket Exempt : No

Product Code : QAS

Prescription Use : Yes

Device Count : 1

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