# K100102: CS-Series-FP

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: Aug 31, 2010 after 230 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 7 generations back to K912470 (1991). 23 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K052884: Model DFP-8000D/FPD Digital Radiography System with Flat Panel Detector, Toshiba America Medical Systems, In.C (2005) Summary page 1.
- K993037: LCV+ Version 2, Ge Medical Systems, Inc. (2000) Summary page 4.
- K020055: Philips Integris Allura 9 with FD Option, Philips Medical Systems (2002) Summary page 1.
- K021021: Modular Angiography System Axiom Artis, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K070834: CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations), Omega Medical Imaging, Inc. (2007) Summary page 1.

## Most influential descendants
- K121293: CS-Series-FP with 3030+Option (2012), 7 descendants of its own
- 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

## Indications for use
The Omega Medical Imaging, Inc. CS-series-FP (SSXI) 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/K100102
Methodology: https://510kreport.com/methodology