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FDA-cleared K233749

Revolution Ascend Sliding

GE Hangwei Medical Systems Co., Ltd.

Authorized purpose: Revolution Ascend Sliding produces cross-sectional images by computer reconstruction of X-ray transmission data, including axial, cine, helical, cardiac, and gated acquisitions, with or without contrast. The FDA indication covers head, whole-body, cardiac, and vascular CT in patients of all ages and use for diagnosis and for planning, guiding, and monitoring therapy.

Modality
CT/CTA
Anatomy
Head, whole body, heart, and vascular anatomy
Decision
2024-02-22
FDA-cleared K192956

Auto Positioning

GE Hangwei Medical Systems, Co., Ltd.

Authorized purpose: Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a technologist-approved first scout.

Modality
CT/CTA
Anatomy
Multi-region
Decision
2020-01-16