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FDA 510(k)

Athena GTX Device Management Suite (ADMS) Software

K-Number: K173203 · 2018-03-14

ApplicantAthena Gtx
Decision Date2018-03-14
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Athena GTX Device Management Suite (ADMS) Software is a medical device manufactured by Athena Gtx. It received FDA 510(k) clearance on 2018-03-14 under approval number K173203. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Athena GTX Device Management Suite (ADMS) Software?

Athena GTX Device Management Suite (ADMS) Software is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Athena Gtx. The 510(k) number is K173203.

When was Athena GTX Device Management Suite (ADMS) Software approved by the FDA?

Athena GTX Device Management Suite (ADMS) Software received FDA 510(k) clearance on 2018-03-14, under approval number K173203.

What company makes Athena GTX Device Management Suite (ADMS) Software?

Athena GTX Device Management Suite (ADMS) Software is manufactured by Athena Gtx.

What is the FDA product code for Athena GTX Device Management Suite (ADMS) Software?

The FDA product code for Athena GTX Device Management Suite (ADMS) Software is MSX.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 42107714 Global approval and certification of ophthalmic AI devices: A comparative regulatory perspective. Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) (2026)

Other Devices by Athena Gtx

K160582WiCap K153459TACVAC K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCap

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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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