# K902005: Model B-200 C-Arm & Model C-300 Cardiac Table

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, Inc.
- Decided: Sep 20, 1990 after 139 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062647: E-View Fluoroscopy System, Model CS-50 (2006), 10 descendants of its own
- K070834: CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations) (2007), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K902005
Methodology: https://510kreport.com/methodology