FDA 510(k)

3DICOM MD Cloud

K-Number: K253784 · 2026-01-08

Decision Date2026-01-08

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3DICOM MD Cloud is the device name listed in this FDA 510(k) record. The listed applicant is Singular Health Pty, Ltd.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) 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. The listed applicant is Singular Health Pty, Ltd.. The 510(k) number is K253784.

When did 3DICOM MD Cloud receive FDA 510(k) clearance?

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

Who is the listed applicant for 3DICOM MD Cloud?

The FDA 510(k) record lists Singular Health Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for 3DICOM MD Cloud is LLZ.

Other records listing Singular Health Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2224703Dicom MD

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.