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FDA-cleared K212442

Cydar EV (Series B) and Cydar EV Maps

Cydar Ltd.

Authorized purpose: Cydar EV and Cydar EV Maps support the labeled endovascular workflow by processing and displaying patient-specific vascular imaging and maps for trained procedural professionals under direct clinical control.

Modality
Fluoroscopy/Angiography
Anatomy
Peripheral vascular and endovascular anatomy
Decision
2021-12-03
FDA-cleared K160088

Cydar EV

Cydar Ltd.

Authorized purpose: Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy from a previously acquired contrast-enhanced diagnostic CT scan onto live fluoroscopic images to assist positioning guidewires, catheters, and other endovascular devices. It is intended for fluoroscopy-guided endovascular procedures in the lower thorax, abdomen, and pelvis, including AAA and mid-distal TAA repair, angioplasty, stenting, and embolization in specified iliac arteries and corresponding veins, and is not intended for liver, kidney, or pelvic-organ procedures.

Modality
Fluoroscopy/Angiography
Anatomy
Lower thorax, abdomen, and pelvis; iliac vessels and corresponding veins
Decision
2016-07-07