Cleared Special

K113486 - VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM

K113486 is an FDA 510(k) clearance for VOLCANO S5I INTRAVASCULAR ULTRACOUND IM..., manufactured by Volcano Corporation. The device is a Class 2 Radiology device with product code IYO cleared through the Special 510(k) pathway after a 65-day FDA review.

K113486 · Volcano Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
65d
Days
Class 2
Risk

K113486 is an FDA 510(k) clearance for the VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 65 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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

FDA 510(k) Submission Details - K113486

510(k) Number K113486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2011
Decision Date January 27, 2012
Days to Decision 65 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 674
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K113486.
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K120201 · Ge Vingmed Ultrasound AS · Apr 2012
BLADDER SCANNER
K113304 · MEDA Co., Ltd. · Mar 2012
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
K112539 · Leiker Regulatory & Quality Consulting · Jan 2012
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K113632 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Jan 2012
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
K113680 · Soma Access Systems, LLC · Dec 2011
DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K113153 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2011