K253784 is an FDA 510(k) clearance for the 3DICOM MD Cloud. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Singular Health Pty, Ltd. (Leederville, AU). The FDA issued a Cleared decision on January 8, 2026, 43 days after receiving the submission on November 26, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K253784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2025 |
| Decision Date | January 08, 2026 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |