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FDA 510(k)

Vios Central Station Monitor Software, Vios Central Server Software

K-Number: K173107 · 2018-07-26

ApplicantVios Medical, Inc.
Decision Date2018-07-26
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vios Central Station Monitor Software, Vios Central Server Software is a medical device manufactured by Vios Medical, Inc.. It received FDA 510(k) clearance on 2018-07-26 under approval number K173107. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vios Central Station Monitor Software, Vios Central Server Software?

Vios Central Station Monitor Software, Vios Central Server Software is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by Vios Medical, Inc.. The 510(k) number is K173107.

When was Vios Central Station Monitor Software, Vios Central Server Software approved by the FDA?

Vios Central Station Monitor Software, Vios Central Server Software received FDA 510(k) clearance on 2018-07-26, under approval number K173107.

What company makes Vios Central Station Monitor Software, Vios Central Server Software?

Vios Central Station Monitor Software, Vios Central Server Software is manufactured by Vios Medical, Inc..

What is the FDA product code for Vios Central Station Monitor Software, Vios Central Server Software?

The FDA product code for Vios Central Station Monitor Software, Vios Central Server Software is DXJ.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

Other Devices by Vios Medical, Inc.

K172586Vios Monitoring System™ Model 2050

Related Devices (Code: DXJ)

K162012CARESCAPE Central Station V2GE Healthcare K170460Sorin ConnectSorin Group Deutschland GmbH K170537Nexxis OR, NexxisBarco N.V. K161880NIVR58-T kitBarco N.V. K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH

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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