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U.S. Department of Health and Human Services

Product Classification

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Device neurological stereotaxic instrument, real-time intraoperative mri
Regulation Description Stereotaxic instrument.
Definition To aid the surgeon in planning and conducting general stereotactic neurosurgery in an mri suite.
Physical State Software: aquire MR images, trajectory planning, guidance regarding alignment of targeting frame with planned trajectory, confirmation of final tool position (MR compatible tools only). Hardware: stereotaxic frame and accessories (e.g. various diameter guide tubes, MRI-visible marking grid to facilitate identifying burr hole location on skull).
Technical Method Device software receives real-time, intraoperative MR images of the brain target and the trajectory of the targeting frame attached to the patient's skull. Software and MRIs are used to plan trajectory, guide alignment of frame with planned trajectory, and confirm final position of surgical tool (MR compatible tools only).
Target Area skull and brain
Regulation Medical Specialty Neurology
Review Panel Ear Nose & Throat
Product CodeORR
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible