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FDA 510(k)

Avatar Medical Software V1

K-Number: K222035 · 2023-05-24

ApplicantAvatar Medical
Decision Date2023-05-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Avatar Medical Software V1 is a medical device manufactured by Avatar Medical. It received FDA 510(k) clearance on 2023-05-24 under approval number K222035. 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 Avatar Medical Software V1?

Avatar Medical Software V1 is a medical device that received FDA 510(k) clearance on 2023-05-24. It is manufactured by Avatar Medical. The 510(k) number is K222035.

When was Avatar Medical Software V1 approved by the FDA?

Avatar Medical Software V1 received FDA 510(k) clearance on 2023-05-24, under approval number K222035.

What company makes Avatar Medical Software V1?

Avatar Medical Software V1 is manufactured by Avatar Medical.

What is the FDA product code for Avatar Medical Software V1?

The FDA product code for Avatar Medical Software V1 is LLZ.

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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: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. 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)

Other Devices by Avatar Medical

K252665brAIn™ Shoulder Positioning K243292brAIn™ Shoulder Positioning K253950Avatar Medical Vision

Related Devices (Code: LLZ)

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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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