3DICOM MD Cloud— 510(k) K253784
Substantially EquivalentSingular Health Pty, Ltd.
FDA 510(k) clearance K253784 for 3DICOM MD Cloud, Substantially Equivalent on 2026-01-08. Applicant: Singular Health Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Singular Health Pty, Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leederville, AU
Recent devices under product code LLZ
view allMore clearances from Singular Health Pty, Ltd.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . 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.