Surgical Information Sciences, Inc. radiology AI products

FDA-cleared K162830

SIS Software

Surgical Information Sciences, Inc.

SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion,...

Modality: MRI
Anatomy: N/A
Decision: 2017-02-14

MRI workflow

FDA-cleared K183019

SIS Software version 3.3.0

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-03-19

CT/CTA workflow

FDA-cleared K192304

SIS Software Version 3.6.0

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-09-13

CT/CTA workflow

FDA-cleared K210071

SIS System (Version 5.1.0)

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-03-31

CT/CTA workflow

FDA-cleared K223032

SIS System (Version 5.6.0)

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-11-21

CT/CTA workflow

FDA-cleared K230977

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-05-02

CT/CTA workflow

FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

Image analysis/processing.

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-06-14

CT/CTA workflow