FDA device listing
Linear Array LA48,MEPHYSTO,MP1 Acrylic Water Tank,MP1 Water Phantom,MP2 Acrylic Water Tank,MP3-M Water Phantom,MP3-P45…
FDA device listing 1609991220 · PTW Freiburg
Key facts
| Proprietary names | Linear Array LA48,MEPHYSTO,MP1 Acrylic Water Tank,MP1 Water Phantom,MP2 Acrylic Water Tank,MP3-M Water Phantom,MP3-P45 Water Phantom,MP3-P Water Phantom,MP3-T Water Phantom,MP3 Water Phantom,MP3-XS Water Phantom,SCANLIFT,SLA48 2D-Air Scanner,Stationary water phantom,TBA Control Pendant,TBA Control Unit |
|---|---|
| Owner/operator | PTW Freiburg |
| Owner/operator number | 9010117 |
| Premarket submissions | K954165 |
| Product codes | IYE |
| Device names | IYE - Accelerator, Linear, Medical |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.5050 |
| Review panels | Radiology |
| Registered establishments | PTW FREIBURG |
| Establishment registrations | 9681124 |
| FEI numbers | 3007360740 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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