Home / Companies / Invivo Corporation

Invivo Corporation

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
29
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0126-2021Class IIIMR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to pSeptember 14, 2020
Z-1440-2020Class IIMonitor for the Functional Imaging System for Magnetic Resonance Imaging SystemFebruary 6, 2020
Z-0462-2019Class IIXper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388September 24, 2018
Z-3192-2018Class IIXper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388August 3, 2018
Z-1867-2018Class IIPHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564March 14, 2018
Z-1289-2018Class IIDynaCad software consist of an MR Analysis Server software and the viewer workstation software. TheJanuary 24, 2018
Z-2115-2018Class IIXper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to November 20, 2017
Z-0263-2018Class IIXper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart andAugust 18, 2017
Z-0082-2018Class IIXper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is used to fAugust 11, 2017
Z-2688-2016Class IIInvivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1May 6, 2016
Z-2760-2016Class IIThe system provides the ability to transmit patient data files for storage, viewing and analysis at October 19, 2015
Z-0958-2015Class IIPhilips Expression MR200 MRI Patient Monitoring System.October 22, 2014
Z-2867-2016Class IIPhilips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secoSeptember 14, 2014
Z-0001-2015Class IIPhilips Expression MR200 MRI Patient Monitoring System Model 866120September 8, 2014
Z-0069-2015Class IIPhilips Expression MR200 MRI Patient Monitoring SystemSeptember 5, 2014
Z-2270-2014Class IIPhilips IP5 Information Portal The Expression Information Portal (Model IP5), a display and devicJune 30, 2014
Z-0983-2014Class IIInvivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary dDecember 4, 2013
Z-1096-2014Class IIInvivo Corporation Expression IP5 Information Portal Product Usage: The Expression InformatiOctober 3, 2013
Z-0468-2013Class IIInvivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient MonitorinOctober 15, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds SmallDecember 23, 2021
K212227Philips MR Patient Care PortalSeptember 30, 2021
K212175DynaCADAugust 2, 2021
K193403UroNav SystemDecember 27, 2019
K192200DynaCADOctober 9, 2019
K182561UroNav (Version 3.0)October 19, 2018
K162177dS FootAnkle I6CH 1.5T CoilSeptember 14, 2016
K1620011.5T and 3.0T 16 CH GE Shoulder CoilsAugust 31, 2016
K152330Expression MR400 MRI Patient Monitoring SystemDecember 23, 2015
K153073UroNav (Version 2.0)November 16, 2015
K133030DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)January 22, 2014
K132359MRI PATIENT MONITORING SYSTEMAugust 30, 2013
K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALJuly 15, 2013
K124061MRI PATIENT MONITORING SYSTEM (MODEL 865214)February 22, 2013
K122897SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645December 21, 2012
K122646DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0TNovember 2, 2012
K121424EXPRESSION INFORMATION PORTALJune 13, 2012
K120122SENSE MSK S 8CH 1.5TFebruary 10, 2012
K1116731.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COILDecember 23, 2011
K103700ESSENTIAL MRI PATIENT MONITORMarch 15, 2011