FDA device listing
Siemens 12L3,Siemens 5P1,Siemens 8V3
FDA device listing 1215692289 · LBN Medical ApS
Key facts
| Proprietary names | Siemens 12L3,Siemens 5P1,Siemens 8V3 |
|---|---|
| Owner/operator | LBN Medical ApS |
| Owner/operator number | 10055731 |
| Premarket submissions | K232145 |
| Product codes | ITX, IYN, IYO, OIJ, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, OIJ - Biopsy Needle Guide Kit, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | LBN MEDICAL A/S |
| Establishment registrations | 3009196578 |
| FEI numbers | 3009196578 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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