Company ยท US
Invivo Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2021. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
21recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 25 |
| MOS | Coil, Magnetic Resonance, Specialty | 23 |
| LLZ | System, Image Processing, Radiological | 8 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| DQA | Oximeter | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2021 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coil Invivo Corporation | MOS |
| Sep 30, 2021 | K212227 | Philips MR Patient Care Portal Invivo Corporation | MWI |
| Aug 2, 2021 | K212175 | DynaCAD Invivo Corporation | LLZ |
| Dec 27, 2019 | K193403 | UroNav System Invivo Corporation | LLZ |
| Oct 9, 2019 | K192200 | DynaCAD Invivo Corporation | LLZ |
| Oct 19, 2018 | K182561 | UroNav (Version 3.0) Invivo Corporation | LLZ |
| Sep 14, 2016 | K162177 | dS FootAnkle I6CH 1.5T Coil Invivo Corporation | MOS |
| Aug 31, 2016 | K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils Invivo Corporation | MOS |
| Dec 23, 2015 | K152330 | Expression MR400 MRI Patient Monitoring System Invivo Corporation | MWI |
| Nov 16, 2015 | K153073 | UroNav (Version 2.0) Invivo Corporation | LLZ |
| Jan 22, 2014 | K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) Invivo Corporation | LLZ |
| Aug 30, 2013 | K132359 | MRI PATIENT MONITORING SYSTEM Invivo Corporation | MWI |
| Jul 15, 2013 | K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL Invivo Corporation | MWI |
| Feb 22, 2013 | K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) Invivo Corporation | MWI |
| Dec 21, 2012 | K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 Invivo Corporation | MOS |
| Nov 2, 2012 | K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T Invivo Corporation | MOS |
| Jun 13, 2012 | K121424 | EXPRESSION INFORMATION PORTAL Invivo Corporation | MWI |
| Feb 10, 2012 | K120122 | SENSE MSK S 8CH 1.5T Invivo Corporation | MOS |
| Dec 23, 2011 | K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL Invivo Corporation | MOS |
| Mar 15, 2011 | K103700 | ESSENTIAL MRI PATIENT MONITOR Invivo Corporation | DQA |
| Jan 3, 2011 | K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL Invivo Corporation | MOS |
| Mar 5, 2010 | K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS Invivo Corporation | MOS |
| Feb 1, 2010 | K093284 | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL Invivo Corporation | MOS |
| Dec 15, 2009 | K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 Invivo Corp. | MWI |
| Aug 21, 2009 | K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 Invivo | MOS |
| Nov 6, 2008 | K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL Invivo | MOS |
| Oct 15, 2008 | K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL Invivo | MOS |
| Jun 17, 2008 | K081262 | DC NEURO Invivo Corporation | LLZ |
| Nov 16, 2007 | K072874 | LBS-127-16 BREAST ARRAY COIL Invivo | MOS |
| Nov 16, 2007 | K072873 | LBS-63-16 BREAST ARRAY COIL Invivo | MOS |
| Oct 13, 2006 | K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS Invivo Corporation | MOS |
| Oct 12, 2006 | K062144 | ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 Invivo Corporation | MHX |
| Aug 2, 2006 | K061675 | VISION VXC CENTRAL STATION, MODEL 4300 Invivo Corporation | MHX |
| Jul 28, 2006 | K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 Invivo | MOS |
| Jan 18, 2006 | K053462 | 3160 MRI PATIENT MONITORING SYSTEM Invivo Corporation | MWI |
| Nov 16, 2005 | K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS Invivo Corporation | MOS |
| Nov 3, 2005 | K052704 | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE Invivo Corp. | MOS |
| Oct 12, 2005 | K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A Invivo Corp. | MOS |
| Jun 28, 2005 | K051512 | CAC-127-8 CARDOAC ARRAY COIL Invivo Corp. | MOS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2020 | Invivo Corporation MR Coils
The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. Terminated |
MOS | K033567 K053017 +2 |
| Feb 6, 2020 | Invivo Corporation Monitor for the Functional Imaging System for Magnetic Resonance Imaging System Terminated |
LNH | K023130 |
| Sep 24, 2018 | Invivo Corporation Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 Completed |
DQK | K101571 |
| Aug 3, 2018 | Invivo Corporation Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 Terminated |
MWI | K101571 |
| Apr 2, 2018 | Invivo Corporation DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for othe Terminated |
LLZ | K121517 K133030 |
| Mar 14, 2018 | Invivo Corporation PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only)
The Xper Flex Cardio physiomonitoring system is used t Terminated |
MWI | None listed |
| Nov 20, 2017 | Invivo Corporation Xper Flex Cardio Physiomonitoring System
The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant Open, Classified |
MWI | K101571 |
| Aug 18, 2017 | Invivo Corporation Xper Flex Cardio Physiomonitoring system.
Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. Terminated |
MWI | K101571 |
| Aug 11, 2017 | Invivo Corporation Xper Flex Cardio PhysioMonitoring system
The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant Terminated |
MWI | K101571 |
| May 6, 2016 | Invivo Corporation Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. Terminated |
MOS | K100113 |
| Oct 19, 2015 | Invivo Corporation The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device. Terminated |
MWI | K101571 |
| Jan 13, 2015 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System. Terminated |
MWI | K131382 |
| Oct 15, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Terminated |
MWI | K131382 |
| Oct 1, 2014 | Invivo Corporation Philips Expression MR200 MRI Patient Monitoring System Model 866120 Terminated |
MWI | K131382 |
| Sep 14, 2014 | Invivo Corporation Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 Terminated |
MWI | K121424 |
| Aug 19, 2014 | Invivo Corporation Philips IP5 Information Portal
The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care pr Terminated |
MWI | K121424 |
| Feb 26, 2014 | Invivo Corporation Invivo Corporation Expression IP5 Information Portal
Product Usage:
The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is int Terminated |
MWI | K121424 |
| Feb 14, 2014 | Invivo Corporation Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device monitors the vital signs of a patient undergoing an MRI proced Terminated |
MWI | K121424 |
| Dec 4, 2012 | Invivo Corporation Invivo Corporation Expression MRI Patient Monitoring System.
The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoin Terminated |
MWI | K090785 |
| Oct 27, 2011 | Invivo Corporation Radio used in the Precess MRI Patient Monitoring System. 3160 (Precess) and HE97B, 94044, 94045 (radio and radio kits).
Label located on the back of the WPU. Product is labeled in part: "***In Terminated |
MWI | K053462 |
| Oct 25, 2011 | Invivo Corporation "***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI Patient Monitoring System Model 865214***Use only with Model 989803169201 Power Adapter***REF 453564 Terminated |
MWI | K090785 |
| Feb 6, 2009 | Invivo Corporation 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826
These rechargeab Terminated |
MWI | K053462 K063559 |