Data / Medical devices / United States / Invivo Corporation

Invivo Corporation: FDA-registered device maker in Orlando, FL, United States, 5 510(k) clearances

Name: Invivo Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Invivo Corporation is registered with the FDA (registration 1051786) in Orlando, FL, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 30, 2021. 19 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Invivo Corporation

FDA registration number: 1051786
Address: 12151 Research Pkwy, Orlando, FL, United States, 32826
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Specification developer
First device listed: January 27, 2010
Registered through: 2026
Brand names listed: 2-CH Patch, 40494E, Limb Clamp Electrode, ADVANCED FILTER ECG CABLE - 989803170121, Advanced Apps ECG Cable - 989803176381, Anesthetic Oxygen (O2) Sensor - 989803162051, BTP-1000P (Patch), CAB,4 LD,CV MRI ECG - 9223, CAB,4 LD,MRI ECG - 9224 and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Electrocardiograph	DRX	2	Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Specification developer	accessdata.fda.gov
Recorder, Paper Chart	DSF	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 30, 2021	K212227	Philips MR Patient Care Portal	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 23, 2015	K152330	Expression MR400 MRI Patient Monitoring System	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
July 15, 2013	K131382	EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
February 22, 2013	K124061	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	MWI	Substantially Equivalent	Invivo Corporation	accessdata.fda.gov
December 15, 2009	K090785	MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214	MWI	Substantially Equivalent	Invivo Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 24, 2018	81092	Class II	Completed	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 wave	accessdata.fda.gov
August 3, 2018	80761	Class II	Terminated	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.	accessdata.fda.gov
March 14, 2018	79611	Class II	Terminated	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	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.	accessdata.fda.gov
November 20, 2017	80057	Class II	Ongoing	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 C	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.	accessdata.fda.gov
August 18, 2017	78585	Class II	Terminated	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	accessdata.fda.gov
August 11, 2017	78465	Class II	Terminated	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, respo	Intermittent communication between the host system and the Flex Cardio	accessdata.fda.gov
October 19, 2015	73196	Class II	Terminated	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	accessdata.fda.gov
October 22, 2014	69587	Class II	Terminated	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.	accessdata.fda.gov
September 14, 2014	74296	Class II	Terminated	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 Monitorin	Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.	accessdata.fda.gov
September 8, 2014	69192	Class II	Terminated	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.	accessdata.fda.gov
September 5, 2014	69179	Class II	Terminated	Philips Expression MR200 MRI Patient Monitoring System	Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.	accessdata.fda.gov
June 30, 2014	68956	Class II	Terminated	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 remote	The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.	accessdata.fda.gov
December 4, 2013	67387	Class II	Terminated	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 cont	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.	accessdata.fda.gov
October 3, 2013	67424	Class II	Terminated	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	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.	accessdata.fda.gov
October 15, 2012	63643	Class II	Terminated	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	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.	accessdata.fda.gov
September 23, 2011	60025	Not yet classified	Terminated	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 Resea	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.	accessdata.fda.gov
August 30, 2010	58984	Not yet classified	Terminated	"*Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826Made in U.S.A.MRI Patient Monitoring System Model 865214Use only with Model 989803169201 Power AdapterREF 453564155341*SN US114016	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.	accessdata.fda.gov
August 13, 2008	50790	Not yet classified	Terminated	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	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 oc	accessdata.fda.gov
September 16, 2005	33936	Not yet classified	Terminated	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.	accessdata.fda.gov

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Updated September 30, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.