Cleared Special

VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS

K140291 · Volcano Corporation · Radiology
Mar 2014
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K140291 is an FDA 510(k) clearance for the VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Volcano Corporation (Billerica, US). The FDA issued a Cleared decision on March 7, 2014, 30 days after receiving the submission on February 5, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K140291 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2014
Decision Date March 07, 2014
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

Similar Devices — IYO System, Imaging, Pulsed Echo, Ultrasonic

All 889
QT Scanner 2000 Model A
K253898 · QT Imaging Holdings, Inc. · Mar 2026
IntraSight Plus
K253714 · Philips Image Guided Therapy Corporation · Feb 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · Eieling Technology (Shenzhen) Limited · Feb 2026
Astrasono A3Pro Bladder Scanner (A3Pro)
K250331 · Astrasono Technology Co., Ltd. · Sep 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · DeepSight Technology, Inc. · Aug 2025
B-Scan
K243227 · Accutome, Inc. Doing Business AS Keeler USA · Jul 2025