Neurology · 510(k) · 2018
RightEye Vision System
RightEye, LLC. Cleared by FDA on 28 September 2018 under submission K181771, product code GWN (nystagmograph). What FDA's record says, in FDA's words.
Device record · K181771
- Device. RightEye Vision SystemDEVICE
- Company. RightEye, LLCCOMPANY
- Decision. 28 September 2018, 510(k), substantially equivalent (traditional review); received 3 July 2018DECISION
- Panel. NeurologyPANEL
- Product code. GWN, NystagmographCODE
- Regulation. 21 CFR 882.1460, Class IIREG
- Source. FDA database entry · decision document (6 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
Recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. Recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. Device Technology Eye-tracking system with pre-loaded software on manufacturer-provided hardware. Eye-tracking system with pre-loaded software on manufacturer-provided hardware. Eye tracking method Includes a remote camera and light source for recording eye movement. Stimuli are presented to the user via a monitor as the projection surface to elicit involuntary eye movements. The function and intent are identical. Includes a remote camera and light source for recording eye movement. Stimuli are presented to the user via a monitor as the projection surface to elicit involuntary eye movements. The function and intent are identical. Software Has software which records the eye tracking methods for patient’s eye movements (fixation, pursuit and saccade) while he/she follows the stimulus. This software function is performed to support the recording, viewing and analyzing of horizontal and vertical eye movements. 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. Has software which records the eye tracking methods for patient’s eye movements (fixation, pursuit and saccade) while he/she follows the stimulus. This software function […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 18 reports filed against devices carrying product code GWN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
26 September 2025 · Malfunction · MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT · NATUS MEDICAL INCORPORATED · report 2023988-2025-00106
MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - DURING THE IMPLANTATION PROCESS, IT WAS FOUND THAT THE SILICONE TUBE OF THE VENTRICULAR CHANNEL WAS BROKEN.
19 November 2024 · Malfunction · MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT · NATUS MEDICAL INCORPORATED · report 2023988-2024-00080
MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - USER COULD NOT CONTINUE WITH PROCEDURE DUE TO PRESSURE ISSUES. THE PATIENT WAS ADMITTED TO THE NEUROSURGERY WARD OF THE HOSPITAL DUE TO CEREBRAL HERNIA. THE PATIENT WAS SCHEDULED FOR SURGERY. INTRAOPERATIVE INTRACRANIAL PRESSURE MONITORING COULD NOT MEASURE THE PRESSURE, THE OPERATION WAS DELAYED, AND THE READING RETURNED TO NORMAL AFTER REPLACING NEW DEVICES. NO INJURIES.
11 July 2024 · Malfunction · COMPACT PORTABLE NEUROMONITOR (ICP AND ICT) · NATUS MEDICAL INCORPORATED · report 2023988-2024-00047
PART CAM02 - DISPLAY ISSUE.
15 April 2024 · Malfunction · MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT · NATUS MEDICAL INCORPORATED · report 2023988-2024-00027
MICRO VENTRICULAR BOLT ICP / TEMP. MONITORING KIT - LEAKAGE OF CSF. NO DELAY IN SURGERY. NO INJURIES.
18 January 2024 · Injury · INSIGHT PRO INFRARED VIDEO GOGGLES · VESTIBULAR FIRST · report 3017632068-2024-00001
PATIENT CONTACTED VESTIBULAR FIRST ON 22-DEC-2023 AND REPORTED POSSIBLE ALLERGIC REACTION AROUND EYE AREA AFTER ASSESSMENT WITH INSIGHT PRO GOGGLES ON 20-DEC-2023. THE ALLERGIC REACTION WAS NOT AT THE AREAS WHERE THE GOGGLES CONTACT SKIN AT THE FOREHEAD, SIDE OF CHEEKS AND NOSE BRIDGE, BUT WAS AT THE EYE AREA THAT DOES NOT HAVE CONTACT WITH THE GOGGLES (EYELID AND BELOW THE EYE). FACILITY ROUTINELY USES MEMBER'S MARK DISINFECTING WIPES BETWEEN PATIENTS' USE. MSDS FOR MEMBER'S MARK INCLUDES […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code GWN, in Neurology, or cleared in 2018. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.