FDA-cleared K221624
Avenda Health AI Prostate Cancer Planning Software
Avenda Health, Inc.
Authorized purpose: Adjunctive review of MR prostate images and biopsy findings for prostate segmentation, lesion evaluation, quantification, documentation, and pre-planning biopsy or soft-tissue-ablation procedures.
- Modality
- MRI
- Anatomy
- Prostate
- Decision
- 2022-11-22