Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AlluraClarity live interventional image-guidance system.
AlluraClarity includes Philips' ClarityIQ technology and provides imaging for a range of clinical procedures, such as catheter-based treatment of obstructed coronary arteries, brain aneurysms, heart rhythm disorders, and defective heart valves, according to the firm.
The device was commercially introduced outside the U.S. in mid-2012, and since then more than 200 systems have been ordered, Philips said.
