FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2024-06-14
FDA-cleared K230977

SIS System

Surgical Information Sciences, Inc.

SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2023-05-02
FDA-cleared K162830

SIS Software

Surgical Information Sciences, Inc.

SIS Software fuses brain MRI with postoperative CT to visualize and localize the subthalamic nucleus for stereotactic neurosurgical planning.

Modality
MRI
Anatomy
Brain
Decision
2017-02-14