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FDA 510(k)

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)

K-Number: K253224 · 2026-01-28

ApplicantImpediMed Limited
Decision Date2026-01-28
Product CodeOBH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) is a medical device manufactured by ImpediMed Limited. It received FDA 510(k) clearance on 2026-01-28 under approval number K253224. The device is classified under product code OBH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) is a medical device that received FDA 510(k) clearance on 2026-01-28. It is manufactured by ImpediMed Limited. The 510(k) number is K253224.

When was MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) approved by the FDA?

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) received FDA 510(k) clearance on 2026-01-28, under approval number K253224.

What company makes MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?

MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) is manufactured by ImpediMed Limited.

What is the FDA product code for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)?

The FDA product code for MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) is OBH.

Related Clinical Trials

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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)

Other Devices by ImpediMed Limited

K172507SOZO K172122SOZO K180126SOZO K190529SOZO K193410SOZO Body Fluid Analyzer K203473SOZO

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K172122SOZOImpediMed Limited K180126SOZOImpediMed Limited K220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd. K230530SOZO ProImpediMed Limited

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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