# K160611: P-Artis

- Pathway: 510(k) (Traditional)
- Applicant: P-Cure, Ltd.
- Decided: Aug 8, 2016 after 158 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033357: Acqsim-Multislice-CT, Model 453567042271, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 4.
- K991600: Somatom Plus 4 with Sliding Gantry Option, Siemens Corp. (1999) Summary page 4.

## Most influential descendants
- K250970: Marie (2025), 0 descendants of its own

## Indications for use
The P-ARTIS CT scanner is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system is intended for scanning patients while seated.

Source page: https://510kreport.com/device/K160611
Methodology: https://510kreport.com/methodology