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FDA-cleared K240773

VisAble.IO

Techsomed

Authorized purpose: VisAble.IO is CT and MR image-processing software for liver-ablation procedures. It imports images from CT and MR scanners and facility PACS systems, assists physicians with ablation-target identification and virtual ablation-needle placement, and assists confirmation of ablation zones.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Liver, hepatic and portal veins, ablation targets, and ablation zones
Decision
2024-04-15
FDA-cleared K223639

VisAble.IO

TechsoMed

Authorized purpose: VisAble.IO is a CT image-processing software package for liver-ablation procedures that imports CT images from CT scanners and facility PACS, assists physicians in identifying ablation targets and planning virtual ablation-needle placement, and assists in confirming ablation zones.

Modality
CT/CTA
Anatomy
Liver and ablation targets
Decision
2023-08-28