FDA device listing
Cartridge 10A,Cartridge 10B,Cartridge 10C,Cartridge 10D,Cartridge 80A,Cartridge 80B,Cartridge 80C,Cartridge…
FDA device listing 1078131340 · Blue Physics
Key facts
| Proprietary names | Cartridge 10A,Cartridge 10B,Cartridge 10C,Cartridge 10D,Cartridge 80A,Cartridge 80B,Cartridge 80C,Cartridge 80D,Cartridge 80E,Model 10.0 Dose Capture,Model 11.0 Dose Capture |
|---|---|
| Owner/operator | Blue Physics |
| Owner/operator number | 10088391 |
| Product codes | LHO |
| Device names | LHO - Instrument, Quality-Assurance, Radiologic |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1940 |
| Review panels | Radiology |
| Registered establishments | BLUE PHYSICS |
| Establishment registrations | 3026580836 |
| FEI numbers | 3026580836 |
| Establishment operations | 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