# K240839: OpenRad Cloud

- Pathway: 510(k) (Traditional)
- Applicant: Openrad Services Uk, Ltd.
- Decided: Apr 24, 2024 after 28 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: 9 generations back to K942120 (1994). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063107: 3DNET Suite, Biotronics3D, Ltd. (2006) Summary page 4.
- K202335: Ambra ProViewer, Dicom Grid Inc Dba Ambra Health (2020) Summary page 4.

## Indications for use
OpenRad Cloud PACS and Viewer is intended for use in the medical image analysis and diagnosis workflows of hospitals, imaging centres, radiologists, reading practices and any user who requires and is granted access to a patient image and associated demographic and report information, including Peer Review or Teleradiology providers. OpenRad Cloud PACS Viewer displays, modifies, and manages diagnostic quality DICOM images, including 3D visualisation and reordering functionality. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography display. The device is not intended for use with mobile displays. Review of images require an optimum display of images. Only use cleared monitors and printers for diagnosis review of images. Follow the maintenance and care instructions given in the manufacturer’s documentation.

Source page: https://510kreport.com/device/K240839
Methodology: https://510kreport.com/methodology