K133323 is an FDA 510(k) clearance for the VOLCANO IFR MODALITY. 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 March 14, 2014 after a review of 136 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.
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510(k) Summary PDF or remain unpublished.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