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510(k) K181785

Modified BrainScope One by Brainscope Company, Inc. — Product Code PIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2018
Date Received
July 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
Device Class
Class II
Regulation Number
882.1450
Review Panel
NE
Submission Type

A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

Other clearances by Brainscope Company, Inc.

  • K190815 — BrainScope TBI (September 11, 2019)
  • K183241 — BrainScope TBI (Model: Ahead 400) (February 19, 2019)
  • K181179 — BrainScope One (May 18, 2018)
  • K161068 — Ahead 300 (September 22, 2016)
  • K143643 — Brainscope Ahead 200 (May 15, 2015)
  • DEN140025 — BrainScope Ahead 100 (November 17, 2014)
  • K082886 — ZOOM-100DC (August 10, 2009)

Other clearances for product code PIW

  • K243426 — Nurochek-Pro System (March 27, 2025)
  • K231914 — Nurochek-II System (December 27, 2023)
  • K190815 — BrainScope TBI (September 11, 2019)
  • K183241 — BrainScope TBI (Model: Ahead 400) (February 19, 2019)
  • K181179 — BrainScope One (May 18, 2018)
  • K161068 — Ahead 300 (September 22, 2016)
  • K143643 — Brainscope Ahead 200 (May 15, 2015)
  • DEN140025 — BrainScope Ahead 100 (November 17, 2014)