510(k) K253784
K253784 is an FDA 510(k) premarket notification submitted by Singular Health Pty, Ltd. for the device "3DICOM MD Cloud". The FDA issued a decision of Substantially Equivalent on Jan 8, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Singular Health Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 8, 2026
- Date Received
- Nov 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type