|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
intrasight mobile
|
Volcano Corporation
|
K203719 |
01/19/2021
|
intrasight
|
Volcano Corporation
|
K190078 |
02/11/2019
|
s5 intravascular ultrasound imaging and pressure systems, s5i intravascular ultrasound imaging and pressure systems, core precision guided therapy system, core mobile precision guided therapy system
|
Volcano Corporation
|
K173860 |
04/11/2018
|
core m2 vascular system, core m2 software v4.2 upgrade kit, core m2 software v4.2 installation kit
|
Volcano Corporation
|
K172455 |
10/25/2017
|
core m2 vascular system
|
Volcano Corporation
|
K170385 |
04/06/2017
|
sw v3.5 install kit, core mobile, sw v3.5 install kit, core, sw v3.5 install kit, s5iz
|
VOLCANO CORPORATION
|
K153369 |
12/22/2015
|
volcano ifr modality, ifr scout feature
|
VOLCANO CORPORATION
|
K150441 |
03/20/2015
|
volcano ifr harvest software (offline)
|
Volcano Corporation
|
K143122 |
02/20/2015
|
volcano ifr modality
|
VOLCANO CORPORATION
|
K133323 |
03/14/2014
|
volcano core control pad, accessory to the volcano s5/s5i intravascular ultrasound imaging & pressure systems
|
VOLCANO CORPORATION
|
K140291 |
03/07/2014
|
|