FDA device listing
RayPilot Extension plate,RayPilot HypoCath,RayPilot Matching Network,RayPilot Power box,RayPilot Quality Control…
FDA device listing 1087517863 · HA2 Medizintechnik GmbH
Key facts
| Proprietary names | RayPilot Extension plate,RayPilot HypoCath,RayPilot Matching Network,RayPilot Power box,RayPilot Quality Control kit,RayPilot Receiver,RayPilot Software,RayPilot System Cable,RayPilot Table displacement meter,RayPilot Transmitter Cable,RayPilot Transmitter tester,RayPilot ViewCath |
|---|---|
| Owner/operator | HA2 Medizintechnik GmbH |
| Owner/operator number | 10042677 |
| Product codes | IYE |
| Device names | IYE - Accelerator, Linear, Medical |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.5050 |
| Review panels | Radiology |
| Registered establishments | HA2 MEDIZINTECHNIK GMBH |
| Establishment registrations | 3009039068 |
| FEI numbers | 3009039068 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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