RightEye Vision System

K181771

RightEye, LLC · cleared 2018-09-28 · product code GWN · Neurology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The RightEye Vision System is designed to run on Windows 10 operating systems and the web portal has been optimized for Chrome. RightEye Vision System is programmed to run on a specific hardware setup, the Tobii Dynavox i15. It is deployed as a pre-loaded system on hardware provided and managed by RightEye.”
Algorithmproprietary algorithms
source quote (p.5)
“The software uses proprietary algorithms to perform the analysis for the reporting of involuntary and voluntary eye movements but the function and intent are identical.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.4)
“All personal health information data are encrypted with HTTPS (HTTP Secure) protocol.”

Validation studies (1)

Bench

sample size not stated

endpoints: test-retest reliability; accuracy

standards: FDA's May 2005 guidance document entitled, "Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

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
1
MAUDE reports in code, 12mo
-62%
vs code's own 3-yr baseline
0
drift signals on this device

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/K181771