FDA-Device2016-12-28Class II
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Philips Electronics North America Corporation
Hazard
Possibility that a patient or user may be exposed to a very small level of touch current.
Sold states
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
Affected count
9
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0825-2017Don't want to check this manually?
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