FFRct definition
FFRct means a coronary vascular physiologic simulation software prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion), which is intended to generate results for use and review by a qualified clinician, de novo 510(k) clearance of which was received on November 26, 2014 for version 1.4 of the HeartFlow Analysis (DEN130045), 510(k) clearance for version 2.x of the Heartflow Analysis was received in January 2016 (510(k) No.: K152733), and 510(k) clearance for a modification to the intended use language in August 2016 (510(k) No.: K161772). Additional clearances were received for a strategic architecture scope change in December 2018 (510(k) No.: K182035), and for the addition of Planner capabilities in August 2019 (510(k) No.: K190925). The Borrower submitted its version 3.x for FDA review in November 2020 and received FDA clearance on January 8, 2021 (510(k) No.: K203329).