K143122 is an FDA 510(k) clearance for the Volcano iFR Harvest Software (Offline). Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.
Submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 112 days - within the typical 510(k) review window.
This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.
Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.
NCT01740895
Completed
Observational
Industry-sponsored
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
A Prospective, Observational, Non-randomized, Double Blind, Global, Multi-center Registry With an Adaptive Design, Investigating the Diagnostic Utility of Instantaneous Wave-free Ratio™ (iFR®) in Assessing Coronary Stenosis Relevance.
| Condition studied |
Cardiovascular Disease |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Javier Escaned, MD |
| Sponsor |
Volcano Corporation
(industry)
|
Started 2012-12-01
→
Primary completion 2013-06-01
Primary outcome
Hemodynamic Severity
Secondary outcome
Specificity
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov