FDA-cleared K242171

TechCare Trauma

Milvue

Aids clinicians and radiologists reviewing 2D X-ray radiographs by detecting, localizing, and characterizing fractures across the FDA-listed appendicular, hip/pelvis, clavicle,...

Modality
X-ray/Radiography
Anatomy
MSK
Decision
2025-01-17
FDA-cleared K232410

SmartChest

Milvue

Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...

Modality
X-ray/Radiography
Anatomy
Chest/lung
Decision
2024-05-10