3DICOM MD Cloud— 510(k) K253784

Substantially Equivalent

Singular Health Pty, Ltd.

FDA 510(k) clearance K253784 for 3DICOM MD Cloud, Substantially Equivalent on 2026-01-08. Applicant: Singular Health Pty, Ltd..

Clearance details

Applicant: Singular Health Pty, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-11-26
Decision date: 2026-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leederville, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.