Magnetoencephalograph
The Magnetoencephalograph (product code OLY) is a Class 2 neurological device regulated under 21 CFR 882.1400 in the Neurology specialty (NE), cleared via 510(k). It acquires, displays, stores, and archives biomagnetic signals produced by electrically active nerve tissue in the brain, providing information about the spatial location of active nerve tissue responsible for certain brain functions relative to brain anatomy. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OLY
- Device Class
- FDA class 2
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191785 | Orion LifeSpan MEG | Feb 14, 2020 | Substantially Equivalent | Compumedics Limited |
| K152184 | MagView BIOMAGNETOMETER SYSTEM | Apr 08, 2016 | Substantially Equivalent | Tristan Technologies, Inc. |
| K133419 | BABYMEG BIOMAGNETOMETER SYSTEM | Jul 21, 2014 | Substantially Equivalent | Tristan Technologies, Inc. |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | May 07, 1997 | Substantially Equivalent | Biomagnetic Technologies, Inc. |
| K962764 | NEUROMAG-122 | Oct 31, 1996 | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. |
| K854466 | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | Feb 04, 1986 | Substantially Equivalent | Biomagnetic Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.