# K121293: CS-Series-FP with 3030+Option

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, LLC
- Decided: Jul 26, 2012 after 87 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: 8 generations back to K912470 (1991). 24 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100102: CS-Series-FP, Omega Medical Imaging, Inc. (2010) Summary page 2.

## Most influential descendants
- K182834: CS-series-FP with Optional ROI Accessory CA-100S (2019), 4 descendants of its own
- K212336: Soteria.AI (2021), 1 descendant of its own
- K171755: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (2018), 1 descendant of its own
- K242488: Soteria E-View (2025), 0 descendants of its own
- K212890: Nyquist.IQ (2021), 0 descendants of its own

## Indications for use
The Omega Medical Imaging, LLC CS-series-FP with 3030+ Option systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Source page: https://510kreport.com/device/K121293
Methodology: https://510kreport.com/methodology