FDA device listing
Angiolux Family,Athlon Family,CHRONON Family,DURA Family,Gigalix Family,Megalix Cat Family,Megalix Cat Plus…
FDA device listing 1087903259 · Siemens Healthineers AG
Key facts
| Proprietary names | Angiolux Family,Athlon Family,CHRONON Family,DURA Family,Gigalix Family,Megalix Cat Family,Megalix Cat Plus Family,Megalix Family,Opti Family,Optilix Family,OPTIPHOS Family,Optitop Family,P40 MoW-100G,RAY Family,S3P-Monoblock,SIREPHOS Family,SMB Family,STRATON Family,TR Family,Vectron Family |
|---|---|
| Owner/operator | Siemens Healthineers AG |
| Owner/operator number | 8010024 |
| Product codes | ITY |
| Device names | ITY - Assembly, Tube Housing, X-Ray, Diagnostic |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1760 |
| Review panels | Radiology |
| Registered establishments | Siemens Healthineers AG, SIEMENS X-RAY VACUUM TECHNOLOGY LTD. |
| Establishment registrations | 3000275399, 3002808157, 3004977335, 3011569702 |
| FEI numbers | 3000275399, 3002808157, 3004977335, 3011569702 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Specification Developer |
| 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