# K242810: RadUnity (Version 1.0.0)

- Pathway: 510(k) (Traditional)
- Applicant: Radunity Corp.
- Decided: Nov 26, 2024 after 69 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: 7 generations back to K913770 (1991). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061214: Aquariusaps Server, Terarecon,Inc. (2006) Summary page 6.
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 6.

## Indications for use
RadUnity receives medical images from CT imaging acquisition devices adhering to the DICOM protocol for image transfer. RadUnity performs image management and digital image processing (centralized specification and reformatting) on the data. The processed images are transferred using the DICOM protocol to other devices supporting this standard protocol. RadUnity is indicated for use by qualified radiology professionals and specialists. RadUnity is not intended for primary diagnostic review. RadUnity is not intended for mammographic image review or interpretation.

Source page: https://510kreport.com/device/K242810
Methodology: https://510kreport.com/methodology