# K070834: CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: May 18, 2007 after 52 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: 6 generations back to K912470 (1991). 13 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040675: Axiom Artis U, Siemens Medical Systems, Inc. (2004) Summary page 1.
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 1.
- K062647: E-View Fluoroscopy System, Model CS-50, Omega Medical Imaging, Inc. (2006) Summary page 1.

## Most influential descendants
- K100102: CS-Series-FP (2010), 8 descendants of its own
- 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

## Indications for use
The Omega Medical Imaging, Inc. CS-Series systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Source page: https://510kreport.com/device/K070834
Methodology: https://510kreport.com/methodology