ETG-100 Optical Encephalography System
by Hitachi Medical Systems America, Inc.
510(k) K011320
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011320 | Date9 Aug 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The ETG-100 Optical Encephalography System is a medical device classified as an optical encephalograph, designed to monitor cerebral hemodynamics and oxygenation by measuring changes in light absorption within brain tissue. It provides non-invasive functional imaging to assess regional blood flow and volume dynamics, aiding in the evaluation of neurological conditions.
This system is intended for use in clinical settings, including operating rooms and intensive care units, where continuous or intermittent monitoring of brain activity is required. Supplied as a reusable device, it operates under sterile conditions when used in direct patient care. The ETG-100 adheres to FDA 510(k) clearance (K011320) under the Oximeter classification (Regulation 870.2700) and is intended for cardiovascular-related applications, as reviewed by the Anesthesiology advisory committee.
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Questions
AI-generated answers, 19 Sep 2026
What clinical settings is the ETG-100 Optical Encephalography System primarily used in, and why is it beneficial for those environments?
The ETG-100 is designed for use in clinical settings like operating rooms and intensive care units, where continuous or intermittent monitoring of brain activity is critical. Its non-invasive functional imaging capability allows for real-time assessment of cerebral hemodynamics and oxygenation, which is particularly useful in high-risk procedures or critical patient care scenarios where brain perfusion and oxygenation must be closely tracked.
Is the ETG-100 Optical Encephalography System intended for single-use or reusable applications, and how does this impact its use in sterile environments?
The ETG-100 is supplied as a reusable device, meaning it is not designed for single-use. When used in direct patient care, it must adhere to sterile conditions, which implies proper cleaning, disinfection, and sterilization protocols must be followed between uses to ensure patient safety and device reliability.
What type of regulatory clearance does the ETG-100 Optical Encephalography System hold, and how does this relate to its intended use?
The ETG-100 holds FDA 510(k) clearance under the Oximeter classification (Regulation 870.2700), with a decision of 'Substantially Equivalent' and reviewed by the Anesthesiology advisory committee. While classified under cardiovascular-related applications, its intended use is for monitoring cerebral hemodynamics and oxygenation, which indirectly supports cardiovascular and neurological patient care.
How does the ETG-100 Optical Encephalography System measure brain activity, and what specific physiological parameters does it assess?
The ETG-100 measures brain activity through optical encephalography, which detects changes in light absorption within brain tissue. This non-invasive method allows it to assess regional blood flow and volume dynamics, providing insights into cerebral hemodynamics and oxygenation—key parameters for evaluating neurological conditions and ensuring proper brain perfusion during critical procedures.