Invivo Corporation
Orlando, FL, US
INVIVO CORPORATION appears in FDA device records in Orlando, FL. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Invivo Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Witt Biomedical Corporation510(k), recall
- Xhale Assurance, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 50 510(k) clearances for Invivo Corporation between 1988 and 2021. The busiest year on record is 2006, with 6. The most recent is 2021, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 6 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 Coils for 1.5T and 3.0T | MOS | Substantially Equivalent | |
| K212227 | Philips MR Patient Care Portal | MWI | Substantially Equivalent | |
| K212175 | DynaCAD | LLZ | Substantially Equivalent | |
| K193403 | UroNav System | LLZ | Substantially Equivalent | |
| K192200 | DynaCAD | LLZ | Substantially Equivalent | |
| K182561 | UroNav (Version 3.0) | LLZ | Substantially Equivalent | |
| K162177 | dS FootAnkle I6CH 1.5T Coil | MOS | Substantially Equivalent | |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | MOS | Substantially Equivalent | |
| K152330 | Expression MR400 MRI Patient Monitoring System | MWI | Substantially Equivalent | |
| K153073 | UroNav (Version 2.0) | LLZ | Substantially Equivalent | |
| K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | LLZ | Substantially Equivalent | |
| K132359 | MRI PATIENT MONITORING SYSTEM | MWI | Substantially Equivalent | |
| K131382 | EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL | MWI | Substantially Equivalent | |
| K124061 | MRI PATIENT MONITORING SYSTEM (MODEL 865214) | MWI | Substantially Equivalent | |
| K122897 | SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 | MOS | Substantially Equivalent | |
| K122646 | DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T | MOS | Substantially Equivalent | |
| K121424 | EXPRESSION INFORMATION PORTAL | MWI | Substantially Equivalent | |
| K120122 | SENSE MSK S 8CH 1.5T | MOS | Substantially Equivalent | |
| K111673 | 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL | MOS | Substantially Equivalent | |
| K103700 | ESSENTIAL MRI PATIENT MONITOR | DQA | Substantially Equivalent | |
| K103149 | 1.5T 16-CHANNEL HAND-WRIST COIL | MOS | Substantially Equivalent | |
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS | MWI | Substantially Equivalent | |
| K093842 | 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS | MOS | Substantially Equivalent | |
| K093284 | 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | MWI | Substantially Equivalent | |
| K091902 | 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484 | MOS | Substantially Equivalent | |
| K082987 | HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL | MOS | Substantially Equivalent | |
| K082916 | HRB-127-32 HIGH RESOLUTION BRAIN COIL | MOS | Substantially Equivalent | |
| K081262 | DC NEURO | LLZ | Substantially Equivalent | |
| K072874 | LBS-127-16 BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K072873 | LBS-63-16 BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K063840 | XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION | MWI | Substantially Equivalent | |
| K063547 | CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM | MWI | Substantially Equivalent | |
| K062767 | CTL-63 AND CTL-128 SPINE ARRAY COILS | MOS | Substantially Equivalent | |
| K062144 | ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 | MHX | Substantially Equivalent | |
| K061675 | VISION VXC CENTRAL STATION, MODEL 4300 | MHX | Substantially Equivalent | |
| K061952 | CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 | MOS | Substantially Equivalent | |
| K053462 | 3160 MRI PATIENT MONITORING SYSTEM | MWI | Substantially Equivalent | |
| K053017 | MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS | MOS | Substantially Equivalent | |
| K052704 | MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE | MOS | Substantially Equivalent | |
| K052497 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A | MOS | Substantially Equivalent | |
| K051512 | CAC-127-8 CARDOAC ARRAY COIL | MOS | Substantially Equivalent | |
| K040195 | CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM | LLZ | Substantially Equivalent | |
| K033030 | CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM | MWI | Substantially Equivalent | |
| K010058 | IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK | LLZ | Substantially Equivalent | |
| K973474 | WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS | MHX | Substantially Equivalent | |
| K950436 | WITT BIOMEDICAL SERIES IV | MHX | Substantially Equivalent | |
| K945582 | WITT BIOMEDICAL IMAGE III | LLZ | Substantially Equivalent | |
| K923054 | WITT BIOMEDICAL SERIES II-EP | MHX | Substantially Equivalent | |
| K880258 | WITT BIOMEDICAL VX-80 | DXG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1051786 | 1051786 | INVIVO CORPORATION | 12151 Research Pkwy, Orlando, FL 32826 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MOSCoil, Magnetic Resonance, Specialty
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DRXElectrode, Electrocardiograph
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DSFRecorder, Paper Chart
- LLZSystem, Image Processing, Radiological
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0126-2021 | 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. | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. | Class III | Terminated | |
| Z-1440-2020 | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. | Class II | Terminated | |
| Z-2133-2019 | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult and pediatric patients, (at least 4 years and older and weighing > 15kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision | These Instructions for Use has missing instructions related to the checking and changing of the application site procedure. | Class II | Terminated | |
| Z-0462-2019 | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard | Class II | Completed | |
| Z-3192-2018 | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 | Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault. | Class II | Terminated | |
| Z-1867-2018 | PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. | The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue. | Class II | Terminated | |
| Z-1289-2018 | 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 other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets. | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to display incorrectly when viewed from remote DynaCAD client computers and could result in visually underestimating calculated Ktrans, Kep, and iAUGC values. The defect also impacts DynaCAD s on-the-fly calculation of Apparent Diffusion Coefficient (ADC) maps. If the ADC values are computed on-the-fly by DynaCAD, the ADC values and colors will also display incorrectly if viewed on a remote DynaCAD client. | Class II | Terminated | |
| Z-2115-2018 | 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 such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. | While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window. | Class II | Open, Classified | |
| Z-0263-2018 | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. | Intermittent communication between the host system and the FlexCardio | Class II | Terminated | |
| Z-0082-2018 | 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 such. Its users, responsible to interpret the data made available, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status. | Intermittent communication between the host system and the Flex Cardio | Class II | Terminated | |
| Z-2688-2016 | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. | A diode was inadvertently not assembled into the system, which may result in coil overheating | Class II | Terminated | |
| Z-2760-2016 | 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. | Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze | Class II | Terminated | |
| Z-0958-2015 | 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 of Patient Monitoring or User/Service Electrical Shock. | Class II | Terminated | |
| Z-2867-2016 | 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 MRI Patient Monitoring System. | Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014. | Class II | Terminated | |
| Z-0001-2015 | Philips Expression MR200 MRI Patient Monitoring System Model 866120 | During production, excess metal (aluminum) debris was found stuck to the cling plastic that covers the device's pole assembly. The metallic debris could affect system performance due to the potential for a failure to power up or loss of power. This could result in the loss of monitoring and a delay in diagnosis of the patient. | Class II | Terminated | |
| Z-0069-2015 | Philips Expression MR200 MRI Patient Monitoring System | Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement. | Class II | Terminated | |
| Z-2270-2014 | 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 professionals to remotely monitor the vital signs of patients undergoing MRI procedures. | The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. | Class II | Terminated | |
| Z-0983-2014 | 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 procedure from the MR control room, induction room, or recovery room and then outputs the measured patient data to a hospital information system (HIS). 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 professionals to remotely monitor the vital signs of patients undergoing MRI procedures. | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression Information Portal (Model IP5). Upon power up, the IP5 may fail to produce audio. | Class II | Terminated | |
| Z-1096-2014 | 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 intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters. | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling their Expression Information Portal (Model IP5). Three different IP5 devices lost audio during use. | Class II | Terminated | |
| Z-0468-2013 | 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 undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner. | Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall. | Class II | Terminated | |
| Z-0113-2012 | 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: "***Invivo Corporation 12601 Research Parkway, Orlando, FL 32826***Made in U.S.A.***REF 3160***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Label located on the bottom of the DCU. Product is labeled in part: ***Invivo Corporation 12601 Research Parkway Orlando, FL 32826 Made in U.S.A.***REF 3160DCU***SN***CAUTION: Law in U.S.A. Canada and EU restricts this device to sale by or on the order of of a licensed medical practitioner only.***" Display Controller Unit (DCU) is labeled in part: "***Invivo***PRECESS***". Wireless Processing Unit (WPU) is labeled in part: "***Invivo***". NOTE: WPU AND DCU MAY HAVE THE SAME OR DIFFERENT SERIAL NUMBERS. The radio is responsible for wireless communication between the Wireless Processing Unit and the Display Controller Unit. Precess is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. | Philips Invivo has determined that it is possible for the system's alarm limits and other device settings to spontaneously change without user intervention. This problem is associated with intermittent and frequent loss of communication between the wireless Processing Unit and the Display Controller Unit. | Terminated | ||
| Z-0106-2012 | "***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 453564155341***SN US11401652***". Note: REF 453564155341, REF 453564181201, and 453564180091 are subject to recall. REF is the firms Service Number which identifies the device. Product Usage The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization of the MR scanner. | Philips Invivo Corporation of Orlando, FL is recalling their Expression MRI Patient Monitoring System. During transport of the system's cart with a docked Display Controller Unit (DCU), a front caster (wheel) may become loose and fall off causing the cart to become unbalanced and fall. | Terminated | ||
| Z-0971-2009 | 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 rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules. | Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. The firms investigation shows that the battery failure does not occur when a module is dropped with a ba | Terminated | ||
| Z-0305-06 | Product is a CALYSTO Series IV Physio-monitoring & Information System model # M-S0053. | Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain