Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIS Software version 3.3.0

K-Number: K183019 · 2019-03-19

ApplicantSurgical Information Sciences, Inc.
Decision Date2019-03-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIS Software version 3.3.0 is a medical device manufactured by Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2019-03-19 under approval number K183019. 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 3.3.0?

SIS Software version 3.3.0 is a medical device that received FDA 510(k) clearance on 2019-03-19. It is manufactured by Surgical Information Sciences, Inc.. The 510(k) number is K183019.

When was SIS Software version 3.3.0 approved by the FDA?

SIS Software version 3.3.0 received FDA 510(k) clearance on 2019-03-19, under approval number K183019.

What company makes SIS Software version 3.3.0?

SIS Software version 3.3.0 is manufactured by Surgical Information Sciences, Inc..

What is the FDA product code for SIS Software version 3.3.0?

The FDA product code for SIS Software version 3.3.0 is LLZ.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07385508 Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches RECRUITING NCT07280065 REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool RECRUITING NCT06646250 NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot RECRUITING NCT05399537 Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT RECRUITING NCT04392349 Clinical Study - ES 900 - 2020-2 COMPLETED

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 K192304SIS Software Version 3.6.0 K210071SIS System (Version 5.1.0) K223032SIS System (Version 5.6.0) K230977SIS System K241083SIS System

View all 7 devices →

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑