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FDA-cleared K223133

VisiRad XR

Imidex Inc.

Authorized purpose: VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in patients older than 21 years in outpatient or emergency-department settings.

Modality
X-ray/Radiography
Anatomy
Adult chest and pulmonary nodules or masses 6-60 mm
Decision
2023-08-03