Discovery 24
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- BrainMaster Technologies EUDAMEDAtlantis FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Atlantis II EUDAMEDAtlantis I EUDAMEDEEG Amplifier FDA UDI
- Model / Reference
- Atlantis 4x4 EUDAMEDFDA UDIAtlantis 2x2 EUDAMED390-040 EUDAMED390-030 EUDAMEDAtlantis II 2x2 FDA UDI
- Description
- EEG Amplifier FDA UDI
Identifiers
- Catalog Number
- 390-030 FDA UDI390-040 FDA UDI
- Primary DI / UDI-DI
- 00852391007027 EUDAMEDFDA UDI00852391007003 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852391007003UN EUDAMED0852391007027V4 EUDAMED
- Direct Marketing DI
- 00852391007003 EUDAMED00852391007027 EUDAMED
- 510(k) Number
- K150498 FDA 510(k)
- FDA Product Code
- GWQ FDA 510(k)HCC FDA UDI
- EMDN Code
- Z12100302 ELECTROENCEPHALOGRAPHS EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)882.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Discovery 24 is a Full-Montage Standard Electroencephalograph (EEG), a Class II medical device designed for recording electrical activity in the brain. It provides high-resolution, 24-channel EEG data capture, enabling detailed monitoring of neural signals for diagnostic and research purposes in neurology.
This device is supplied as a reusable, portable system powered via USB, intended for clinical, laboratory, or remote/home use with compatible laptop computers. It is regulated under FDA 510(k) clearance and EU MDR, with a device classification of Class II. The system incorporates low-noise DC-sensitive amplifiers and 24-bit analog-to-digital converters for optimal signal clarity.
Frequently asked questions
What types of environments is the Discovery 24 EEG system designed for, and how is it powered?
The Discovery 24 is a portable EEG system designed for use in clinical settings, laboratories, and even remote or home environments. It connects to a compatible laptop via USB for power, making it flexible for various settings without requiring a dedicated power source.
Is the Discovery 24 system reusable or single-use, and what does this mean for maintenance?
The Discovery 24 is explicitly described as a reusable system, meaning it is built for repeated use across multiple patients or sessions. This design implies it requires regular cleaning, calibration, and maintenance to ensure consistent performance and hygiene standards, though specific cleaning protocols would be provided by the manufacturer.
What kind of signal resolution and technology does the Discovery 24 use for EEG recordings?
The Discovery 24 captures high-resolution EEG data through a 24-channel system with low-noise DC-sensitive amplifiers and 24-bit analog-to-digital converters, ensuring optimal clarity and precision for neural signal monitoring in diagnostic or research applications.
How is the Discovery 24 regulated, and what does this mean for buyers or clinicians?
The Discovery 24 holds FDA 510(k) clearance and is compliant with the EU Medical Device Regulation (MDR), classifying it as a Class II device. This means it has undergone rigorous review by regulatory bodies to ensure safety and performance, but buyers should confirm local compliance requirements before use.
What specialties or applications is the Discovery 24 primarily intended for?
While the device is classified under the Neurology specialty in regulatory filings, it is designed for diagnostic and research purposes in EEG monitoring. This includes applications like epilepsy evaluation, sleep studies, or neurological assessments, though its exact clinical indications would be determined by healthcare professionals based on medical necessity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Discovery 24 Series - BrainMaster Technologies Inc., Discovery Series - BrainMaster Technologies Inc., Discovery 24 Neurofeedback systems by BrainMaster - EEG Sales
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150498 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BrainMaster Technologies, Inc.
Sources (5)
- FDA 510(k) K150498 24 fields · synced Sep 18, 2026
- FDA UDI 4d5ca841-2f8d-4df4-8754-8e9534ce783b 35 fields · synced May 24, 2026
- FDA UDI c1c76735-e603-4ea5-b6cb-2656848e2c9c 35 fields · synced May 30, 2026
- EUDAMED 91249dfb-966b-4d5e-94f3-ecca5d63db2f 61 fields · synced Jul 12, 2026
- EUDAMED 4c85084e-e004-475a-901a-1e8ac1a5e66b 61 fields · synced Jul 16, 2026