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Invivo Corporation

United States·US-MF-000002284

Last updated September 17, 2026

Information

Country: United States
Address: 3545, SW 47th Ave, Gainesville, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: Donna Peled
EUDAMED SRN: US-MF-000002284
FDA FEI Number: 1051786
DUNS Number: —

Catalogue (211)

Page 1 of 5

Device	Model / Reference	Registries	Class	Status
Expression Information Portal	K121424	FDA 510(k)	Class II	Active
dS Anterior 3.0T	459801730121	EUDAMEDFDA UDI	Class IIa	Active
Ds Flex-M 3.0t	453530322425	EUDAMEDFDA UDI	Class IIa	Active
dS Breast 7ch 1.5T	459801729901	EUDAMEDFDA UDI	Class IIa	Active
SENSE NV Coil 3.0T/16ch	453530077123	EUDAMEDFDA UDI	Class IIa	Active
SENSE NV Coil 1.5T/8ch	453530066943	EUDAMEDFDA UDI	Class IIa	Active
Fiducial Marker	453530096542	EUDAMEDFDA UDI	Class I	Active
Ds Flex-M 3.0t	459801729961	EUDAMEDFDA UDI	Class IIa	Active
dS FLEX-L 3.0T	453530322415	EUDAMEDFDA UDI	Class IIa	Active
Lateral Grid dS Breast 16CH I/	989603209143	EUDAMEDFDA UDI	Class I	Active
dS FootAnkle 8Ch 3.0T	459801290801	EUDAMEDFDA UDI	Class IIa	Active
ClarifEye Marker	459801593922	EUDAMEDFDA UDI	Class I	Active
Sentinelle Biopsy Grid [package]	989603216901	EUDAMED	Class I	Active
SENSE Head Coil 3.0T/8ch	453530062953	EUDAMEDFDA UDI	Class IIa	Active
SENSE Breast Coil 7ch	453530074362	EUDAMEDFDA UDI	Class IIa	Active
dS 1.5T Interface Box	459801716341	EUDAMEDFDA UDI	Class IIa	Active
dS WRIST 8Ch 1.5T	459801290531	EUDAMEDFDA UDI	Class IIa	Active
dS 3.0T 1Ch Lateral Left	459801716321	EUDAMEDFDA UDI	Class IIa	Active
SENSE Wrist Coil 1.5T 8ch	453530075831	EUDAMEDFDA UDI	Class IIa	Active
dS 3.0T 4Ch Lateral Left	459801716291	EUDAMEDFDA UDI	Class IIa	Active
dS 1.5T 1Ch Lateral Left	459801716381	EUDAMEDFDA UDI	Class IIa	Active
dS Shoulder 16ch 3.0T	459801312411	EUDAMEDFDA UDI	Class IIa	Active
dS Shoulder 16ch 3.0T	459801728831	EUDAMEDFDA UDI	Class IIa	Active
dS 16CH WRIST 3.0T, COIL	459801728871	EUDAMED	Class IIa	Active
Needle Block Holder	989603203543	EUDAMEDFDA UDI	Class I	Active
dS SmallExtr 8ch 3.0T	459801290871	EUDAMEDFDA UDI	Class IIa	Active
Pillar Immobilization Plate LBS C-C	989603209073	EUDAMEDFDA UDI	Class I	Active
dS Knee 16CH 3.0T	459801730031	EUDAMEDFDA UDI	Class IIa	Active
dS 1.5T 8Ch Medial	459801716371	EUDAMEDFDA UDI	Class IIa	Active
1.5T and 3.0T 16 CH GE Shoulder Coils	K162001	FDA 510(k)	Class II	Active
Hrk-63-16 Knee Array Coil, Hrk-127-16 Knee Array Coil	K082987	FDA 510(k)	Class II	Active
Sense Msk S 8ch 1.5t	K120122	FDA 510(k)	Class II	Active
Lbs-127-16 Breast Array Coil	K072874	FDA 510(k)	Class II	Active
1.5t And 3t 8-Channel Medium General Purpose Flex Coil	K111673	FDA 510(k)	Class II	Active
SaintView	K223660	FDA 510(k)	Class II	Active
UroNav System	K193403	FDA 510(k)	Class II	Active
dS FootAnkle I6CH 1.5T Coil	K162177	FDA 510(k)	Class II	Active
Models Hrs-63-8 And Hrs-127-8 Shoulder Array Coils	K053017	FDA 510(k)	Class II	Active
Dc Neuro	K081262	FDA 510(k)	Class II	Active
Ds Breast 16ch I/T 1.5t Ds Breast 16ch I/T 3.0t	K122646	FDA 510(k)	Class II	Active
Ctl-63 And Ctl-128 Spine Array Coils	K062767	FDA 510(k)	Class II	Active
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	K213766	FDA 510(k)	Class II	Active
UroNav (Version 2.0)	K153073	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Model Bbd Breast Immobilization And Biopsy Device	K052704	FDA 510(k)	Class II	Active
Escort M8 Vital Signs Patient Monitor, Model 3810	K062144	FDA 510(k)	Class II	Active
Vision Vxc Central Station, Model 4300	K061675	FDA 510(k)	Class II	Active
UroNav (Version 3.0)	K182561	FDA 510(k)	Class II	Active
Expression MR400 MRI Patient Monitoring System	K152330	FDA 510(k)	Class II	Active
Lbs-63-16 Breast Array Coil	K072873	FDA 510(k)	Class II	Active
1.0t 8-Channel Panorama Breast Array Coil	K093284	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (22)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 14, 2020	Z-0126-2021	—	terminated	The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.
Feb 6, 2020	Z-1440-2020	—	terminated	Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.
Sep 24, 2018	Z-0462-2019	—	completed	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
Aug 3, 2018	Z-3192-2018	—	terminated	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.
Mar 14, 2018	Z-1867-2018	—	terminated	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.
Jan 24, 2018	Z-1289-2018	—	terminated	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.
Nov 20, 2017	Z-2115-2018	—	open, classified	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.
Aug 18, 2017	Z-0263-2018	—	terminated	Intermittent communication between the host system and the FlexCardio
Aug 11, 2017	Z-0082-2018	—	terminated	Intermittent communication between the host system and the Flex Cardio
May 6, 2016	Z-2688-2016	—	terminated	A diode was inadvertently not assembled into the system, which may result in coil overheating
Oct 19, 2015	Z-2760-2016	—	terminated	Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze
Oct 22, 2014	Z-0958-2015	—	terminated	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.
Sep 14, 2014	Z-2867-2016	—	terminated	Frozen Display Numerics and Disabled Menu Keys after extended run time. This customer notification was sent August 22, 2014.
Sep 8, 2014	Z-0001-2015	—	terminated	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.
Sep 5, 2014	Z-0069-2015	—	terminated	Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
Jun 30, 2014	Z-2270-2014	—	terminated	The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
Dec 4, 2013	Z-0983-2014	—	terminated	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.
Oct 3, 2013	Z-1096-2014	—	terminated	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.
Oct 15, 2012	Z-0468-2013	—	terminated	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.
Sep 23, 2011	Z-0113-2012	—	terminated	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.
Aug 30, 2010	Z-0106-2012	—	terminated	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.
Aug 13, 2008	Z-0971-2009	—	terminated	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