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Invivo Corporation

United States·US-MF-000002284

Last updated September 17, 2026

What Invivo Corporation makes

Invivo Corporation manufactures magnetic resonance imaging (MRI) coils and related accessories, including anterior, breast, foot/ankle, and flex coils for various field strengths (1.5T and 3.0T), as well as fiducial markers and ClarifEye markers used for image guidance and localization in MRI procedures.

The company's devices are classified as Class I, Class II, and Class IIa medical devices and are listed in the EUDAMED database and the FDA 510(k) registry. Invivo Corporation is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Invivo Corporation manufacture?

Where is Invivo Corporation based?

Invivo Corporation is based in the United States, as stated in the provided summary of the company's location.

Which regulatory registries list Invivo Corporation's devices?

Invivo Corporation's devices are listed in the EUDAMED database and the FDA 510(k) registry, which are the two registries explicitly mentioned in the device data.

How are Invivo Corporation's devices classified?

Invivo Corporation's devices are classified as Class I, Class II, and Class IIa medical devices, reflecting the range of risk levels associated with their MRI coils, accessories, and markers as indicated in the device classes field.

AI-generated from registry data and not verified by a human reviewer.

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 2 of 5

Device	Model / Reference	Registries	Class	Status
Cac-127-8 Cardoac Array Coil	K051512	FDA 510(k)	Class II	Active
3160 Mri Patient Monitoring System	K053462	FDA 510(k)	Class II	Active
1.5t 8-Channel Small Extremity Coil, Model 800494, 3.0t 8-Channel Small Extremity Coil, Model 800484	K091902	FDA 510(k)	Class II	Active
1.5t And 3.0t General Purpose Flex Coils	K093842	FDA 510(k)	Class II	Active
Mri Compatible Patient Monitoring System, Model 865214	K090785	FDA 510(k)	Class II	Active
Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645	K122897	FDA 510(k)	Class II	Active
Neurovascular Array Coil, Model Nva-127-16-A	K052497	FDA 510(k)	Class II	Active
Essential Mri Patient Monitor	K103700	FDA 510(k)	Class II	Active
1.5t 16-Channel Hand-Wrist Coil	K103149	FDA 510(k)	Class II	Active
Expression Mr200 Mri Patient Monitoring System, Expression Ip5 Information Portal	K131382	FDA 510(k)	Class II	Active
Dynacad/Prostate Interventional (dynaloc/Prostate)	K133030	FDA 510(k)	Class II	Active
Hrb-127-32 High Resolution Brain Coil	K082916	FDA 510(k)	Class II	Active
Mri Patient Monitoring System (model 865214)	K124061	FDA 510(k)	Class II	Active
Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 And Cac-127-16	K061952	FDA 510(k)	Class II	Active
ClarifEye Needle	459801593902	EUDAMEDFDA UDI	Class IIa	Active
Prostate Needle Guide	989603208694	EUDAMEDFDA UDI	Class I	Active
dS FLEX-M 1.5T	459801729951	EUDAMEDFDA UDI	Class IIa	Active
Needle Block, 18G	989603203483	EUDAMEDFDA UDI	Class I	Active
Grid Immobilization Plate OBC	989603203593	EUDAMEDFDA UDI	Class I	Active
dS FootAnkle Coil 8ch 1.5T	459800766651	EUDAMED	Class IIa	Active
dS FLEX-L 3.0T	459801729942	EUDAMEDFDA UDI	Class IIa	Active
SENSE Head Coil 1.5T/8ch	453530057613	EUDAMEDFDA UDI	Class IIa	Active
dS Breast Coil 7ch 1.5T	459801728811	EUDAMED	Class IIa	Active
Needle Block, 12G	989603203463	EUDAMEDFDA UDI	Class I	Active
dS HeadNeck 1.5T	459801290063	EUDAMEDFDA UDI	Class IIa	Active
dS 1.5T Medial Plug	459801857611	EUDAMEDFDA UDI	Class IIa	Active
dS Wrist Coil 8ch 1.5T	459800766671	EUDAMED	Class IIa	Active
dS Base 1.5T	459801290052	EUDAMEDFDA UDI	Class IIa	Active
SENSE Knee Coil 3.0T/8ch	453530064371	EUDAMEDFDA UDI	Class IIa	Active
dS Breast 16ch 3.0T	459801290744	EUDAMEDFDA UDI	Class IIa	Active
dS 3.0T 16CH SHOULDER, COIL	459801728832	EUDAMEDFDA UDI	Class IIa	Active
dS Breast 16ch 3.0T	459801729891	EUDAMEDFDA UDI	Class IIa	Active
dS HiRes Hand/Wrist 16Ch 1.5T	459801295481	EUDAMEDFDA UDI	Class IIa	Active
Microscopy 47mm Coil, Ingenia 3.0t	459801794482	EUDAMEDFDA UDI	Class IIa	Active
Microscopy 23mm Coil, Ingenia 3.0t	459801730012	EUDAMEDFDA UDI	Class IIa	Active
dS Breast Coil 7ch 1.5T	459800766681	EUDAMEDFDA UDI	Class IIa	Active
MRI Needle Sleeve 12G	989603203493	EUDAMEDFDA UDI	Class I	Active
Grid Immobilization Plate LBS C-C	989603209063	EUDAMEDFDA UDI	Class I	Active
dS Breast 7ch 3.0T	459801729911	EUDAMEDFDA UDI	Class IIa	Active
dS Head 1.5T	459801290043	EUDAMEDFDA UDI	Class IIa	Active
dS Shoulder 8 ch 3.0T	459801290831	EUDAMEDFDA UDI	Class IIa	Active
SENSE Spine coil 3.0T 15-ch	453530093184	EUDAMEDFDA UDI	Class IIa	Active
Needle Sleeve 18G	989603203513	EUDAMEDFDA UDI	Class I	Active
dS SMALL EXTREMITY 16CH 1.5T, COIL	459801728791	EUDAMED	Class IIa	Active
dS Knee 16CH 1.5T	459801730021	EUDAMEDFDA UDI	Class IIa	Active
Needle Sleeve 14G	989603203503	EUDAMEDFDA UDI	Class I	Active
Flex, Medium, 3t, Irf	459801729962	EUDAMEDFDA UDI	Class IIa	Active
dS WRIST 8Ch 3.0T	459801290771	EUDAMEDFDA UDI	Class IIa	Active
SENSE Foot-Ankle Coil	453530090163	EUDAMEDFDA UDI	Class IIa	Active
SENSE Knee Coil 16ch	453530104186	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Philips Medical Systems Nederland B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

The FDA recall records for Invivo Corporation show 22 recall records, with the earliest initiated on 2008-08-13 and the most recent on 2020-09-14. The recorded statuses of these recalls include completed, open, classified, and terminated. The reasons given for the recalls include issues such as device malfunction, spontaneous changes to system settings, excess metal debris, and inaccurate display values. The records list various products, including the Expression Information Portal, MR 200 devices, and the Expression MRI Patient Monitoring System, with specific problems identified for each product.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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