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FDA-cleared K250738

YSIO X.pree

Siemens Medical Solutions

Authorized purpose: YSIO X.pree is a digital X-ray system for whole-body radiographic imaging, including skull, chest, abdomen, and extremities, to support diagnostic and therapeutic decisions.

Modality
X-ray/Radiography
Anatomy
Whole body, including skull; chest; abdomen; and extremities
Decision
2025-07-31
FDA-cleared K250660

LUMINOS Q.namix T; LUMINOS Q.namix R

Siemens Medical Solutions

Authorized purpose: LUMINOS Q.namix T and LUMINOS Q.namix R are multifunctional radiography and fluoroscopy systems for routine radiography and fluoroscopic examinations including gastrointestinal, urogenital, arthrographic, angiographic, and pediatric workflows; they are not mammography systems.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2025-07-14
FDA-cleared K233543

YSIO X.pree

Siemens Medical Solutions

Authorized purpose: YSIO X.pree is a digital X-ray system designed to visualize anatomical structures and generate X-ray images from the whole body, including the skull, chest, abdomen, spine, limbs, and extremities, for review by qualified healthcare professionals.

Modality
X-ray/Radiography
Anatomy
Skull, chest, abdomen, spine, extremities, limbs, and trunk
Decision
2024-05-21