OLY
6 FDA 510(k) clearances · Product code
247 daysmedian time to decision
324 days90th percentile
6clearances measured
FDA profile
- Official device name
- Magnetoencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Medical specialty
- Neurology
- Flags
- Third-party review eligible
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Orion LifeSpan MEG (K191785) | Compumedics Limited | 2020-02-14 |
| MagView BIOMAGNETOMETER SYSTEM (K152184) | Tristan Technologies, Inc. | 2016-04-08 |
| BABYMEG BIOMAGNETOMETER SYSTEM (K133419) | Tristan Technologies, Inc. | 2014-07-21 |
| MAGNES 2500 WH BIOMAGNETOMETER (K962317) | Biomagnetic Technologies, Inc. | 1997-05-07 |
| NEUROMAG-122 (K962764) | Philips Medical Systems (Cleveland), Inc. | 1996-10-31 |
| BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER (K854466) | Biomagnetic Technologies, Inc. | 1986-02-04 |
Track OLY automatically
Every clearance here is in the API, with alerts when new ones post.