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FDA-cleared K242188

ClearRead CT CAC

Riverain Technologies, Inc.

Authorized purpose: Aids physicians in assessing coronary artery calcification on non-gated, non-contrast standard- or low-dose chest CT.

Modality
CT/CTA
Anatomy
Chest/coronary arteries
Decision
2024-12-03
FDA-cleared K213566

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

Authorized purpose: Notification-only triage of adult chest x-rays for suspected pneumothorax at least 5 mm.

Modality
X-ray/Radiography
Anatomy
Lungs
Decision
2022-03-10