# K173076: CURA 16; ScintCare CT16

- Pathway: 510(k) (Traditional)
- Applicant: Fmi Medical Systems, Inc.
- Decided: Oct 4, 2018 after 370 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: 8 generations back to K982349 (1998). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151752: SOMATOM Emotion 6/16, Siemens Medical Solutions USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K192590: CURA 778 (2020), 0 descendants of its own

## Indications for use
The CURA CT16/ScintCare CT16 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 system is suitable for all patients.

Source page: https://510kreport.com/device/K173076
Methodology: https://510kreport.com/methodology