Surgical Information Sciences Inc.

Address:4602 141st Ln NE,Ham Lake,MN,55304,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Automated Radiological Image Processing Software (QIH) (1)

Premarket Exempt

Clear

SIS System - 00860001580907 Catalog Number :

Device Description : SIS System is a software system intended for use in the viewing, presentation an SIS System is a software system intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively). Typical users of SIS System are medical professionals, including but not limited to surgeons, neurologists, and radiologists.

Device Class : 2

Duns Number: 080367988

Premarket Exempt : No

Product Code : QIH

Prescription Use : Yes

Device Count : 1

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