FDA Device Entity Profile: Invivo Corporation

Known Identifiers & Locations

FEI Numbers 1051786

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K124061	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0001-2015	Philips Expression MR200 MRI Patient Monitoring System Model 866120 Reason: 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.	2014-09-08	Terminated	View Details

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