ScanMed, LLC radiology AI products

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FDA-cleared K212783

ProstatID

ScanMed, LLC

Authorized purpose: Concurrent CADe/CADx reading aid for qualified physicians interpreting prostate MRI in adult males undergoing screening or clinical MRI, including high-risk screening or diagnostic imaging, to identify prostate abnormalities and regions suspicious for cancer and assess their likelihood of malignancy.

Modality: MRI
Anatomy: Prostate
Decision: 2022-07-08

Prostate imaging Detection and CADe