FDA product code OLY: Magnetoencephalograph
OLY is the FDA product code for magnetoencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 6 510(k) submissions under OLY, from 4 different applicants. The average 510(k) review took 208 days (median 236).
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.
Classification
| Field | Value |
|---|---|
| Device name | Magnetoencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OLY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 226 |
Compare with all 510(k) review times · Search every OLY clearance
Top OLY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tristan Technologies, Inc. | 2 | 2016-04-08 |
| Biomagnetic Technologies, Inc. | 2 | 1997-05-07 |
| Compumedics Limited | 1 | 2020-02-14 |
| Philips Medical Systems (Cleveland), Inc. | 1 | 1996-10-31 |
Most recent OLY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191785 | Compumedics Limited | Orion LifeSpan MEG | 2020-02-14 | 226 |
| K152184 | Tristan Technologies, Inc. | MagView BIOMAGNETOMETER SYSTEM | 2016-04-08 | 247 |
| K133419 | Tristan Technologies, Inc. | BABYMEG BIOMAGNETOMETER SYSTEM | 2014-07-21 | 256 |
| K962317 | Biomagnetic Technologies, Inc. | MAGNES 2500 WH BIOMAGNETOMETER | 1997-05-07 | 324 |
| K962764 | Philips Medical Systems (Cleveland), Inc. | NEUROMAG-122 | 1996-10-31 | 107 |
Recalls for OLY devices
openFDA lists no recalls for product code OLY.
Frequently asked questions
What is FDA product code OLY?
OLY is the FDA product code for magnetoencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OLY?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLY?
Across 6 cleared submissions the average was 208 days from receipt to decision (median 236).
Which companies have the most OLY clearances?
Tristan Technologies, Inc. (2); Biomagnetic Technologies, Inc. (2); Compumedics Limited (1); Philips Medical Systems (Cleveland), Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLY
- Run a recall and safety report across every OLY manufacturer
- Watch product code OLY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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