LVIS NeuroMatch
FDA 510(k) K222450 · LVIS Corporation
510(k) numberK222450
Submission
- Device name
- LVIS NeuroMatch
- Applicant
- LVIS Corporation
Palo Alto, CA, US - Received
- August 15, 2022
- Decision date
- June 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMB – Automatic Event Detection Software For Full-Montage Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
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
Other 510(k)s with product code OMB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260998 | Ceribell Neurology Review SoftwareOMB · Traditional | Ceribell, Inc. | 06/24/2026SE |
| K252070 | Ceribell Infant Seizure Detection SoftwareOMB · Traditional | Ceribell, Inc. | 11/21/2025SE |
| K252160 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | Persyst Development, LLC | 10/31/2025SE |
| K243743 | autoSCORE (V 2.0.0)OMB · Traditional | Holberg Eeg AS | 04/09/2025SE |
| K241589 | Ceribell Seizure Detection SoftwareOMB · Traditional | Ceribell, Inc. | 04/09/2025SE |
| K242446 | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))OMB · Traditional | Persyst Development Corporation | 01/22/2025SE |
| K241390 | NeuroMatchOMB · Traditional | LVIS Corporation | 11/26/2024SE |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM)OMB · Traditional | Epitel, Inc. | 10/17/2024SE |
| K240993 | encevis (2.1)OMB · Traditional | Ait Austrian Institute of Technology GmbH | 09/27/2024SE |
| K231068 | autoSCOREOMB · Traditional | Holberg Eeg AS | 01/07/2024SE |
More from Holberg Eeg AS
Questions and answers
When was LVIS NeuroMatch cleared by the FDA?
LVIS NeuroMatch (K222450) received a 510(k) decision of Substantially Equivalent on June 9, 2023, 298 days after the submission was received.
What is the product code of K222450?
The FDA product code is OMB – Automatic Event Detection Software For Full-Montage Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.