# K192590: CURA 778

- Pathway: 510(k) (Traditional)
- Applicant: Fmi Medical Systems, Inc.
- Decided: Mar 5, 2020 after 167 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: 9 generations back to K982349 (1998). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160743: Philips Ingenuity CT, Philips Medical Systems (Cleveland), Inc. (2016) Summary page 4.
- K173076: CURA 16; ScintCare CT16, Fmi Medical Systems, Inc. (2018) Summary page 7.

## Indications for use
The CURA 778 is a Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data collected at different angles and planes. The system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The CURA 778 scanner is a whole body scanner, with cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

Source page: https://510kreport.com/device/K192590
Methodology: https://510kreport.com/methodology