3DICOM MD Cloud

FDA 510(k) K253784 · Singular Health Pty, Ltd.

Substantially Equivalent

510(k) numberK253784

Submission

Device name
3DICOM MD Cloud
Applicant
Singular Health Pty, Ltd.
Leederville, AU
Received
November 26, 2025
Decision date
January 8, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was 3DICOM MD Cloud cleared by the FDA?

3DICOM MD Cloud (K253784) received a 510(k) decision of Substantially Equivalent on January 8, 2026, 43 days after the submission was received.

What is the product code of K253784?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.