# K190024: Smart-C

- Pathway: 510(k) (Abbreviated)
- Applicant: Turner Imaging Systems, Inc.
- Decided: Sep 27, 2019 after 263 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K113708 (2012). 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)
- K113708: Orthoscan Mobile DI Mini C-Arm, Orthoscan, Inc. (2012) Summary page 4.

## Indications for use
The Smart-C is a mini C-arm X-ray system designed to provide physicians with real time general fluoroscopic visualization of adult and pediatric patients. It is intended to aid physicians and surgeons during diagnostic procedures, therapeutic treatment, or surgical procedures of the limbs, extremities, or shoulders including but not limited to, orthopedics and emergency medicine. The Smart-C is intended to be used on a table or other hard flat surface. It may also be used with the optional support stand.

Source page: https://510kreport.com/device/K190024
Methodology: https://510kreport.com/methodology