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FDA 510(k)

Argus Cognitive ReVISION Software

K-Number: K223322 · 2023-07-24

ApplicantArgus Cognitive, Inc.
Decision Date2023-07-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Argus Cognitive ReVISION Software is a medical device manufactured by Argus Cognitive, Inc.. It received FDA 510(k) clearance on 2023-07-24 under approval number K223322. 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 Argus Cognitive ReVISION Software?

Argus Cognitive ReVISION Software is a medical device that received FDA 510(k) clearance on 2023-07-24. It is manufactured by Argus Cognitive, Inc.. The 510(k) number is K223322.

When was Argus Cognitive ReVISION Software approved by the FDA?

Argus Cognitive ReVISION Software received FDA 510(k) clearance on 2023-07-24, under approval number K223322.

What company makes Argus Cognitive ReVISION Software?

Argus Cognitive ReVISION Software is manufactured by Argus Cognitive, Inc..

What is the FDA product code for Argus Cognitive ReVISION Software?

The FDA product code for Argus Cognitive ReVISION Software is LLZ.

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

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Official Source

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