FDA device listing
Polydoros A100 Family,Polydoros ACX,Polydoros F / Polydoros R Family,Polydoros RF Family,Polydoros RFX
FDA device listing 1561588693 · Siemens Healthineers AG
Key facts
| Proprietary names | Polydoros A100 Family,Polydoros ACX,Polydoros F / Polydoros R Family,Polydoros RF Family,Polydoros RFX |
|---|---|
| Owner/operator | Siemens Healthineers AG |
| Owner/operator number | 8010024 |
| Product codes | IZO |
| Device names | IZO - Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1700 |
| Review panels | Radiology |
| Registered establishments | Siemens Healthineers AG, SIEMENS X-RAY VACUUM TECHNOLOGY LTD. |
| Establishment registrations | 3002808157, 3004977335, 3011569702 |
| FEI numbers | 3002808157, 3004977335, 3011569702 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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