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FDA-cleared K222070

EndoNaut

Therenva SAS

Authorized purpose: EndoNaut fuses planning images with live fluoroscopy and provides computerized navigation support for fluoroscopy-guided aneurysm repair, embolization, and peripheral-artery procedures involving the chest, abdomen, pelvis, neck, or lower limbs.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2022-10-25
FDA-cleared K212383

EndoNaut

Therenva SAS

EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm, angioplasty, stenting, and embolization procedures.

Modality
Fluoroscopy/Angiography
Anatomy
Multi-region
Decision
2021-08-31