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FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

Authorized purpose: 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.

Authorized purpose: 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 K192304

SIS Software Version 3.6.0

Surgical Information Sciences, Inc.

Authorized purpose: SIS Software v3.6.0 displays, presents, documents, registers, fuses, and processes brain MR and postoperative CT images to support stereotactic neurosurgery and subthalamic-nucleus visualization.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2019-09-13
FDA-cleared K162830

SIS Software

Surgical Information Sciences, Inc.

Authorized purpose: 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