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FDA 510(k)

3DICOM MD Cloud

K-Number: K253784 · 2026-01-08

ApplicantSingular Health Pty, Ltd.
Decision Date2026-01-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DICOM MD Cloud is a medical device manufactured by Singular Health Pty, Ltd.. It received FDA 510(k) clearance on 2026-01-08 under approval number K253784. 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 3DICOM MD Cloud?

3DICOM MD Cloud is a medical device that received FDA 510(k) clearance on 2026-01-08. It is manufactured by Singular Health Pty, Ltd.. The 510(k) number is K253784.

When was 3DICOM MD Cloud approved by the FDA?

3DICOM MD Cloud received FDA 510(k) clearance on 2026-01-08, under approval number K253784.

What company makes 3DICOM MD Cloud?

3DICOM MD Cloud is manufactured by Singular Health Pty, Ltd..

What is the FDA product code for 3DICOM MD Cloud?

The FDA product code for 3DICOM MD Cloud is 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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