Natus NeuroWorks
FDA 510(k) K180421 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
510(k) numberK180421
Submission
- Device name
- Natus NeuroWorks
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Oakville, CA - Received
- February 16, 2018
- Decision date
- March 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
| 510(k) | Device | Decision |
|---|---|---|
| K242930 | Natus BrainWatch SystemOMC · Traditional | 11/19/2024SE |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro)GWJ · Traditional | 03/08/2024SE |
| K203500 | RetCam EnvisionHKI · Traditional | 04/13/2021SE |
| K200878 | Natus NeuroWorksOMB · Traditional | 05/18/2020SE |
| K173936 | Natus Photic StimulatorGWE · Traditional | 06/15/2018SE |
| K180290 | Natus Brain Monitor AmplifierGWQ · Traditional | 06/14/2018SE |
| K173690 | Grass TWinOLV · Special | 03/09/2018SE |
| K180181 | Natus QuantumGWQ · Special | 02/22/2018SE |
| K172711 | Comet-PLUSOLV · Special | 11/03/2017SE |
| K163163 | XLTEK EMU40EX EEG HeadboxGWQ · Special | 12/14/2016SE |
Questions and answers
When was Natus NeuroWorks cleared by the FDA?
Natus NeuroWorks (K180421) received a 510(k) decision of Substantially Equivalent on March 14, 2018, 26 days after the submission was received.
What is the product code of K180421?
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.