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510(k) K192753

NeuralScan System by Medeia, Inc. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2020
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Medeia, Inc.

  • K212684 — BrainView QEEG Software (January 28, 2023)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K150804 — QBioScan (October 19, 2015)

Other clearances for product code GWQ

  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)
  • K212788 — Seer Home (June 16, 2022)