K253784
- 510(k) number
- K253784
- Device name
- 3DICOM MD Cloud
- Applicant
- Singular Health Pty, Ltd. AU
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-01-08
- Date received
- 2025-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253784.pdf
Official FDA record: K253784
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.