Neurology · 510(k) · 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
Epitel, Inc. Cleared by FDA on 17 October 2024 under submission K240408, product code OMB (automatic event detection software for full-montage electroencephalograph). What FDA's record says, in FDA's words.
Device record · K240408
- Device. REMI-AI Rapid Detection Module (REMI-AI RDM)DEVICE
- Company. Epitel, IncCOMPANY
- Decision. 17 October 2024, 510(k), substantially equivalent (traditional review); received 9 February 2024DECISION
- Panel. NeurologyPANEL
- Product code. OMB, Automatic Event Detection Software For Full-Montage ElectroencephalographCODE
- Regulation. 21 CFR 882.1400, Class IIREG
- Source. FDA database entry · decision document (13 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.
The REMI-AI Rapid Detection Module (REMI-AI RDM) is a seizure detection module which is integrated into the REMI Remote EEG Monitoring System and is only indicated for use within non-ICU (Intensive Care Unit) healthcare settings. REMI-AI RDM has not been validated for and is not indicated for detection of electrographic status epilepticus. REMI-AI RDM conducts automated analysis of REMI EEG data in near real-time and provides notifications of potential electrographic seizures (events) through the REMI System when seizure prevalence of 10% or greater (indicating seizure activity of at least 30 seconds within a 5-minute rolling window) is detected. When seizure prevalence is displayed, the notification also displays the corresponding event detection confidence. Notifications are intended to be used by qualified clinicians who will exercise professional judgment in their application. Detected events are also annotated in the associated REMI EEG record as an aide to the qualified physician’s REMI EEG review. Delays of up to several minutes may occur between the detection of an event and the generation of an event notification, and are thus not a substitute for real-time monitoring. REMI- AI RDM does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI-AI RDM is indicated for use with adult and pediatric patients (6+ years).
The product code's definition, from FDA's classification record. Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 36 reports filed against devices carrying product code OMB. 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:
25 June 2025 · Malfunction · NATUS BRAIN MONITOR BREAKOUT · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00015
PART 021911 NATUS BRAIN MONITOR BREAKOUT - THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.
25 June 2025 · Malfunction · NATUS BRAIN MONITOR BREAKOUT · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00014
PART 021911 NATUS BRAIN MONITOR BREAKOUT - THE CHANNEL LABELS ON THE DEVICE DO NOT MATCH WITH CHANNEL LABELS IN THE RECORDING AND REFER TO A DIFFERENT BRAIN LOCATION, LEADING TO MISREPRESENTATION OF THE EEG DATA.
21 May 2025 · Malfunction · IP PTZ HD ERGOJUST VIDEO EXTENSION · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00013
IP PTZ HD ERGOJUST VIDEO EXTENSION - ERGOJUST CART CHASSIS BREAKING. METAL ON POLE STARTED TO COMPLETELY SHEAR, MAKE SHIFT REPAIR HAS BEEN DONE TO KEEP IT IN PLACE.
27 March 2025 · Malfunction · UPPER MAST ASSEMBLY FOR ERGOJUST CART · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00011
UPPER MAST ASSEMBLY FOR ERGOJUST CART -USER STATED THEY WERE PUSHING THE CART DOWN THE HALL AND THE CAMERA TOWER FELL AND ALMOST HIT THEM ON THE HEAD.
27 March 2025 · Malfunction · UPPER MAST ASSEMBLY FOR ERGOJUST CART · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2025-00012
UPPER MAST ASSEMBLY FOR ERGOJUST CART - SECOND EVENT - USER STATED THEY WERE PUSHING THE CART DOWN THE HALL AND THE CAMERA TOWER FELL AND ALMOST HIT THEM ON THE HEAD. THE SECOND TIME ONE OF THE CAMERA TOWERS BROKE AT THE MOUNTING CONNECTION.
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 OMB, in Neurology, from Epitel, Inc, or cleared in 2024. 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.