# K253784: 3DICOM MD Cloud

- Pathway: 510(k) (Traditional)
- Applicant: Singular Health Pty, Ltd.
- Decided: Jan 8, 2026 after 43 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K162011 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233226: FlexView Diagnostic (v1.1.20), Radical Imaging, LLC (2024) Summary page 6.

## Indications for use
3DICOM MD Cloud is intended for use as a diagnostic and analysis tool for multi-modality medical images and their associated reports and information, enabling qualified healthcare professionals from hospitals, imaging centres, radiologists, and reading practices to view patient images, documents, and related data. 3DICOM MD Cloud enables qualified users to manipulate medical images, create markups, and perform measurements using a range of tools. 3DICOM MD Cloud is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. 3DICOM MD Cloud is not intended for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K253784
Methodology: https://510kreport.com/methodology