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510(k) K112077

HBIDB - HUMAN BRIAN INDEX SOFTWARE by Corscience GmbH & Co. KG — Product Code OLU

K112077 is an FDA 510(k) premarket notification submitted by Corscience GmbH & Co. KG for the device "HBIDB - HUMAN BRIAN INDEX SOFTWARE". The FDA issued a decision of Substantially Equivalent on March 9, 2012. The device falls under product code OLU (Normalizing Quantitative Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Corscience GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2012
Date Received
July 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Normalizing Quantitative Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.

Other clearances by Corscience GmbH & Co. KG

  • K193159 — NeuroAmp II, NeuroAmp II.5s (December 30, 2020)
  • K082077 — BT3/6, BT12 (September 2, 2008)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

Other clearances for product code OLU

  • K253015 — Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (June 12, 2026)
  • K240420 — NeuroField Analysis Suite (September 20, 2024)
  • K222838 — iSyncBrain©-C (March 16, 2023)
  • K212684 — BrainView QEEG Software (January 28, 2023)
  • K202588 — BNA Platform (December 7, 2020)
  • K191432 — cortiQ PRO (January 24, 2020)
  • K171414 — qEEG-Pro (July 1, 2018)
  • K121119 — BNA ANALYSIS SYSTEM (July 25, 2014)
  • K050192 — BRC SOFTWARE PRODUCT (October 20, 2005)
  • K041263 — NEUROGUIDE ANALYSIS SYSTEM (August 3, 2004)

FDA data resources