510(k) K123898 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
| Applicant | Volcano Corporation, Rancho Cordova, CA, US |
| Decision | Substantially Equivalent, Jan 14, 2013 |
| Received | Dec 18, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Volcano Corporation Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07 Terminated |
OBJ | None listed |
| Apr 25, 2016 | Volcano Corporation Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits.
Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qua Terminated |
OBJ | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5.
Radiology: The Volcano s5/s5i and C Terminated |
IYO | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5x.
Radiology: The Volcano s5/s5i and CORE Terminated |
IYO | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model CORE Mobile.
Radiology: The Volcano s5/s5i Terminated |
IYO | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5i
Radiology: The Volcano s5/s5i and CORE Terminated |
IYO | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model s5ix/s5iz
Radiology: The Volcano s5/s5i an Terminated |
IYO | None listed |
| Jul 20, 2015 | Volcano Corporation Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits;
Model CORE
Radiology: The Volcano s5/s5i and COR Terminated |
IYO | None listed |
| Jul 8, 2015 | Volcano Corp Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014;
s5x - 807300-001; CORE MOBILE - 400-0100.01.
Intravascular Ima Terminated |
IYO | None listed |
| Jul 8, 2015 | Volcano Corp Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging
and Pressure System;
Product/Part numbers: s5i -806300-020 ;
s5ix/s5iz - 807400-001;
CORE - 400-0 I 00.02.
Intravascular Imaging and Pr Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.