FDA-cleared K222458

AIBOLIT 3D+

Aibolit Technologies, LLC

Aibolit 3D+ processes, reviews, analyzes, communicates, and exchanges multidimensional digital images acquired from CT and MR devices for preoperative surgical planning, training,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in CT and MR images for preoperative or intraoperative planning
Decision
2023-01-12
FDA-cleared K211443

AIBOLIT 3D+

AIbolit Technologies, LLC

AIBOLIT 3D+ processes, reviews, analyzes, communicates, and interchanges multidimensional digital images acquired from CT to support preoperative surgical planning, training,...

Modality
CT/CTA
Anatomy
Patient-specific anatomy represented in CT images for preoperative and intraoperative planning
Decision
2022-01-07