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FDA 510(k)

SIS Software Version 3.6.0

K-Number: K192304 · 2019-09-13

ApplicantSurgical Information Sciences, Inc.
Decision Date2019-09-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIS Software Version 3.6.0 is a medical device manufactured by Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2019-09-13 under approval number K192304. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS Software Version 3.6.0?

SIS Software Version 3.6.0 is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Surgical Information Sciences, Inc.. The 510(k) number is K192304.

When was SIS Software Version 3.6.0 approved by the FDA?

SIS Software Version 3.6.0 received FDA 510(k) clearance on 2019-09-13, under approval number K192304.

What company makes SIS Software Version 3.6.0?

SIS Software Version 3.6.0 is manufactured by Surgical Information Sciences, Inc..

What is the FDA product code for SIS Software Version 3.6.0?

The FDA product code for SIS Software Version 3.6.0 is LLZ.

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Other Devices by Surgical Information Sciences, Inc.

K162830SIS Software K183019SIS Software version 3.3.0 K210071SIS System (Version 5.1.0) K223032SIS System (Version 5.6.0) K230977SIS System K241083SIS System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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