# K161559: Kuvia3D

- Pathway: 510(k) (Traditional)
- Applicant: 4qimaging, LLC Dba Qmetrics
- Decided: Jun 23, 2016 after 17 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: 1 generation back to K003746 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003746: 3D-Doctor, Able Software Corp. (2001) Summary page 5.

## Indications for use
Kuvia3D software is intended for the display and analysis of DICOM image data to facilitate 3D visualization of joint anatomy for planning surgical and non-surgical therapies.

Source page: https://510kreport.com/device/K161559
Methodology: https://510kreport.com/methodology