FDA device listing
Alta Multipurpose Device
FDA device listing 1493487311 · ELEKTA AB
Key facts
| Proprietary names | Alta Multipurpose Device |
|---|---|
| Owner/operator | ELEKTA AB |
| Owner/operator number | 8030893 |
| Premarket submissions | K193243 |
| Product codes | FRZ, IYE, JAI, JAK, KPS, LHN, LNH, OUO |
| Device names | FRZ - Device, Patient Transfer, Powered, IYE - Accelerator, Linear, Medical, JAI - Couch, Radiation Therapy, Powered, JAK - System, X-Ray, Tomography, Computed, KPS - System, Tomography, Computed, Emission, LHN - System, Radiation Therapy, Charged-Particle, Medical, LNH - System, Nuclear Magnetic Resonance Imaging, OUO - Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6775, 892.1000, 892.1200, 892.1750, 892.5050, 892.5770 |
| Review panels | General Hospital, Radiology |
| Registered establishments | ELEKTA SOLUTIONS AB |
| Establishment registrations | 3015232217 |
| FEI numbers | 3015232217 |
| Establishment operations | Foreign Exporter |
| 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