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FDA-cleared K202990

NinesMeasure

Nines, Inc.

Authorized purpose: Provides semi-automatic measurement of pulmonary-nodule size in adult thoracic CT.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-02-25
FDA-cleared K193351

NinesAI

Nines, Inc.

Authorized purpose: Provides a parallel triage workflow for head CT images with suspected intracranial hemorrhage and/or mass effect for radiologist prioritization.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-04-21