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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device source localization software for electroencephalograph or magnetoencephalograph
Definition Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization
Product CodeOLX
Regulation Number 882.1400
Device Class 2


Premarket Reviews
ManufacturerDecision
ELECTRICAL GEODESICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA NEUROMAG OY
  SUBSTANTIALLY EQUIVALENT 1
EPILOG
  SUBSTANTIALLY EQUIVALENT 1
EXCEL-TECH LTD. (XLTEK)
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGIC LLC
  SUBSTANTIALLY EQUIVALENT 1
RICOH COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Signal Artifact/Noise 1 1
Device Maintenance Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1

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