# K191713: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, LLC
- Decided: Oct 4, 2019 after 100 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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: 10 generations back to K912470 (1991). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182834: CS-series-FP with Optional ROI Accessory CA-100S, Omega Medical Imaging, LLC (2019) Summary page 4.

## Indications for use
The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-1 OOS as a modification device to provide an automated Region of interest that reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-1 OOS be considered as a replacement for the primary collimator. The primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest

Source page: https://510kreport.com/device/K191713
Methodology: https://510kreport.com/methodology