Invivo Corporation
Medical device manufacturer in Florida, FL.
39510(k) clearances
0PMA approvals
22recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…MOS · Traditional | 12/23/2021SE |
| K212227 | Philips MR Patient Care PortalMWI · Traditional | 09/30/2021SE |
| K212175 | DynaCADLLZ · Abbreviated | 08/02/2021SE |
| K193403 | UroNav SystemLLZ · Traditional | 12/27/2019SE |
| K192200 | DynaCADLLZ · Traditional | 10/09/2019SE |
| K182561 | UroNav (Version 3.0)LLZ · Traditional | 10/19/2018SE |
| K162177 | dS FootAnkle I6CH 1.5T CoilMOS · Traditional | 09/14/2016SE |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder CoilsMOS · Traditional | 08/31/2016SE |
| K152330 | Expression MR400 MRI Patient Monitoring SystemMWI · Special | 12/23/2015SE |
| K153073 | UroNav (Version 2.0)LLZ · Traditional | 11/16/2015SE |
| K133030 | Dynacad/Prostate Interventional (Dynaloc/Prostate)LLZ · Traditional | 01/22/2014SE |
| K132359 | MRI Patient Monitoring SystemMWI · Special | 08/30/2013SE |
| K131382 | Expression MR200 MRI Patient Monitoring System, Expression IP5 Information PortalMWI · Special | 07/15/2013SE |
| K124061 | MRI Patient Monitoring System (Model 865214)MWI · Special | 02/22/2013SE |
| K122897 | Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645MOS · Traditional | 12/21/2012SE |
| K122646 | DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0TMOS · Traditional | 11/02/2012SE |
| K121424 | Expression Information PortalMWI · Special | 06/13/2012SE |
| K120122 | Sense MSK S 8CH 1.5TMOS · Special | 02/10/2012SE |
| K111673 | 1.5T and 3T 8-CHANNEL Medium General Purpose Flex CoilMOS · Traditional | 12/23/2011SE |
| K103700 | Essential MRI Patient MonitorDQA · Special | 03/15/2011SE |
| K103149 | 1.5T 16-CHANNEL Hand-Wrist CoilMOS · Traditional | 01/03/2011SE |
| K093842 | 1.5T and 3.0T General Purpose Flex CoilsMOS · Traditional | 03/05/2010SE |
| K093284 | 1.0T 8-CHANNEL Panorama Breast Array CoilMOS · Traditional | 02/01/2010SE |
| K090785 | MRI Compatible Patient Monitoring System, Model 865214MWI · Special | 12/15/2009SE |
| K091902 | 1.5T 8-CHANNEL Small Extremity Coil, Model 800494, 3.0T 8-CHANNEL Small Extremity Coil…MOS · Traditional | 08/21/2009SE |
| K082987 | HRK-63-16 Knee Array Coil, HRK-127-16 Knee Array CoilMOS · Special | 11/06/2008SE |
| K082916 | HRB-127-32 High Resolution Brain CoilMOS · Special | 10/15/2008SE |
| K081262 | DC NeuroLLZ · Traditional | 06/17/2008SE |
| K072874 | LBS-127-16 Breast Array CoilMOS · Special | 11/16/2007SE |
| K072873 | LBS-63-16 Breast Array CoilMOS · Special | 11/16/2007SE |
| K062767 | CTL-63 and CTL-128 Spine Array CoilsMOS · Special | 10/13/2006SE |
| K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810MHX · Traditional | 10/12/2006SE |
| K061675 | Vision VXC Central Station, Model 4300MHX · Special | 08/02/2006SE |
| K061952 | Cardiovascular Array Coils, Models CAC-63-16, CAC-63-32, CAC-123-32 and CAC-127-16MOS · Special | 07/28/2006SE |
| K053462 | 3160 MRI Patient Monitoring SystemMWI · Special | 01/18/2006SE |
| K053017 | Models HRS-63-8 and HRS-127-8 Shoulder Array CoilsMOS · Special | 11/16/2005SE |
| K052704 | Model BBD Breast Immobilization and Biopsy DeviceMOS · Traditional | 11/03/2005SE |
| K052497 | Neurovascular Array Coil, Model NVA-127-16-AMOS · Special | 10/12/2005SE |
| K051512 | CAC-127-8 Cardoac Array CoilMOS · Traditional | 06/28/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0126-2021 Class III | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance…The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that… | 09/14/2020Terminated |
| Z-1440-2020 Class II | Monitor for the Functional Imaging System for Magnetic Resonance Imaging SystemInsufficient shielding of Philips SensaVue DVI Adapter for computer monitor. | 02/06/2020Terminated |
| Z-0462-2019 Class II | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following… | 09/24/2018Completed |
| Z-3192-2018 Class II | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG… | 08/03/2018Terminated |
| Z-1867-2018 Class II | PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901…The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may… | 03/14/2018Terminated |
| Z-1289-2018 Class II | DynaCad software consist of an MR Analysis Server software and the viewer workstation…Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered… | 01/24/2018Terminated |
| Z-2115-2018 Class II | Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is…While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using… | 11/20/2017Open, Classified |
| Z-0263-2018 Class II | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of…Intermittent communication between the host system and the FlexCardio | 08/18/2017Terminated |
| Z-0082-2018 Class II | Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitoring system is…Intermittent communication between the host system and the Flex Cardio | 08/11/2017Terminated |
| Z-2688-2016 Class II | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil…A diode was inadvertently not assembled into the system, which may result in coil overheating | 05/06/2016Terminated |
| Z-2760-2016 Class II | The system provides the ability to transmit patient data files for storage, viewing and…Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze | 10/19/2015Terminated |
| Z-0958-2015 Class II | Philips Expression MR200 MRI Patient Monitoring System.The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss… | 10/22/2014Terminated |
| Z-2867-2016 Class II | Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used…Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent… | 09/14/2014Terminated |
| Z-0001-2015 Class II | Philips Expression MR200 MRI Patient Monitoring System Model 866120During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the… | 09/08/2014Terminated |
| Z-0069-2015 Class II | Philips Expression MR200 MRI Patient Monitoring SystemFailure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. | 09/05/2014Terminated |
| Z-2270-2014 Class II | Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display…The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between… | 06/30/2014Terminated |
| Z-0983-2014 Class II | Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a…Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression… | 12/04/2013Terminated |
| Z-1096-2014 Class II | Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression…Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression… | 10/03/2013Terminated |
| Z-0468-2013 Class II | Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient…Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI… | 10/15/2012Terminated |
| Z-0113-2012 | Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B…Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to… | 09/23/2011Terminated |
| Z-0106-2012 | "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in…Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System.… | 08/30/2010Terminated |
| Z-0971-2009 | 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and…Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer… | 08/13/2008Terminated |