Brainscope Ahead 200

K143643

BRAINSCOPE COMPANY, INC. · cleared 2015-05-15 · product code PIW · Neurology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The BrainScope® Ahead® 200 is comprised of two hardware components: the Handheld Device and the disposable Electrode Headset with patient application supplies. The main software components of the Ahead 200 are the application software and the BrainScope Algorithm Library (BSAL).”
AlgorithmCalculates standard quantitative EEG (qEEG) parameters (Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension) and a discriminant function for structural injury.
source quote (p.7)
“The Ahead® 200 is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (qEEG) parameters from frontal locations on a patient's forehead. The Ahead® 200 calculates and displays raw measures for the following standard qEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. Calculation of a discriminant function for structural injury”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“AES-128 for intra-device communication”

Validation studies (1)

Bench

sample size not stated

endpoints: Software (including User Interface) Verification Testing; Hardware Verification; System Performance and Functionality; Algorithm Performance; Packaging Testing; Basic Safety and Essential Performance; Electromagnetic Compatibility; Biocompatibility; Reliability

standards: ANSI/AAMI ES60601-1:2005/(R)2012, CAN/CSA C22.2 No 601.1-08(R2013), IEC/EN 60601-1:2005+A1:2012, IEC 60601-2-26:2012, IEC/EN 60601-1-2:2007, ISO 10993-1:2009, ANSI/AAMI EC12:2000, ISO 14971: 2000, ASTM D4169-09

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K161068 (decision 2016-09-22) from BRAINSCOPE COMPANY INC for a matching device line ("Ahead 300") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K161068

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K143643