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FDA-cleared K251766

TumorSight Viz

SimBioSys, Inc.

Authorized purpose: TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction, segmentation, 3D renderings, measurements, kinetic curves, parametric maps, MIPs, and reformats for physician visualization and analysis; results are not the sole basis for patient management.

Modality
MRI
Anatomy
Breast
Decision
2025-07-08
FDA-cleared K243189

TumorSight Viz

SimBioSys, Inc.

Authorized purpose: Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable finding visualization; results are not a sole basis for patient management.

Modality
MRI
Anatomy
Breast, including biopsy-proven breast tumors/findings.
Decision
2024-10-25
FDA-cleared K231130

TumorSight Viz

SimBioSys, Inc.

Authorized purpose: TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration, subtraction, measurements, and three-dimensional views to support physician review.

Modality
MRI
Anatomy
Breast; early-stage or locally advanced breast cancer
Decision
2023-12-26