# K212442: Cydar EV (Series B) and Cydar EV Maps

- Pathway: 510(k) (Traditional)
- Applicant: Cydar, Ltd.
- Decided: Dec 3, 2021 after 121 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: 8 generations back to K913770 (1991). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160088: Cydar EV, Cydar, Ltd. (2016) Summary page 5.
- K141475: Endosize, Therenva Sas (2014) Summary page 6.

## Most influential descendants
- K252500: CARA System (2026), 0 descendants of its own

## Indications for use
Cydar EV provides tools to: * Import and visualise CT data * Segment and annotate vascular anatomy from CT data * Place and edit virtual guidewires and measure lengths on them * Make measurements of anatomical structures on planar sections of the CT data * Produce an operative plan from measurements and segmentation of preoperative vessel anatomy * Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned based on the position of anatomical features present in both * Non-rigidly transform the visualisation of anatomy when intra-operative vessel deformation is observed * Post-operatively review data relating to procedures where the system was used Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy. Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan. The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software is therefore not recommended for use in patients under the age of 18. IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the pre-operative position It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device.

Source page: https://510kreport.com/device/K212442
Methodology: https://510kreport.com/methodology