# K081215: Volumina

- Pathway: 510(k) (Traditional)
- Applicant: Kjaya Medical, LLC
- Decided: Aug 26, 2008 after 118 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 K954678 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061672: Synapse Mip/MPR Image Visualization Software Obliquus, Fujifilm Medical Systems U.S.A, Inc. (2006) Summary page 1.
- K033955: RTIST, Mirada Solutions, Ltd. (2004) Summary page 1.

## Indications for use
Volumina enables the display of 3D (MIP/MPR) visualization of CT, PET, and MR studies or other DICOM compliant images. Typical users are radiologists, technologists and clinicians. Not for mammographic purposes.

Source page: https://510kreport.com/device/K081215
Methodology: https://510kreport.com/methodology