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FDA 510(k)

ViewFinder Software Version 1.1

K-Number: K223501 · 2023-04-21

ApplicantElaitra, Ltd.
Decision Date2023-04-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViewFinder Software Version 1.1 is a medical device manufactured by Elaitra, Ltd.. It received FDA 510(k) clearance on 2023-04-21 under approval number K223501. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewFinder Software Version 1.1?

ViewFinder Software Version 1.1 is a medical device that received FDA 510(k) clearance on 2023-04-21. It is manufactured by Elaitra, Ltd.. The 510(k) number is K223501.

When was ViewFinder Software Version 1.1 approved by the FDA?

ViewFinder Software Version 1.1 received FDA 510(k) clearance on 2023-04-21, under approval number K223501.

What company makes ViewFinder Software Version 1.1?

ViewFinder Software Version 1.1 is manufactured by Elaitra, Ltd..

What is the FDA product code for ViewFinder Software Version 1.1?

The FDA product code for ViewFinder Software Version 1.1 is QIH.

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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)

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Official Source

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