FDA device listing
BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 104)
FDA device listing 1075635867 · Brainsway Ltd.
Key facts
| Proprietary names | BrainsWay Deep TMS System for Treatment of Obsessive Compulsive Disorder (OCD) (Model 104) |
|---|---|
| Owner/operator | Brainsway Ltd. |
| Owner/operator number | 10044527 |
| Premarket submissions | K183303 |
| Product codes | QCI |
| Device names | QCI - Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5802 |
| Review panels | Neurology |
| Registered establishments | BRAINSWAY LTD. |
| Establishment registrations | 3010300912 |
| FEI numbers | 3010300912 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database