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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological stereotaxic instrument, real-time intraoperative mri
Definition To aid the surgeon in planning and conducting general stereotactic neurosurgery in an MRI suite.
Product CodeORR
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGI-VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGIVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 2 2
2019 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Unintended Movement 1 1
Imprecision 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Death 1 1
Hemorrhage/Bleeding 1 1

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