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.
View all Volcano Corporation devices
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510(k) Summary PDF or remain unpublished.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