# K222470: 3Dicom MD

- Pathway: 510(k) (Traditional)
- Applicant: Singular Health Pty, Ltd.
- Decided: Oct 25, 2022 after 70 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: 2 generations back to K162011 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200546: ZeeroMED View, O3 Enterprise Srl (2020) Summary page 4.

## Indications for use
3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. 3Dicom MD displays and manages diagnostic quality DICOM images. 3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. 3Dicom MD is not intended for diagnostic use on mobile devices. Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

Source page: https://510kreport.com/device/K222470
Methodology: https://510kreport.com/methodology