FDA device listing
Philips Epiq CVx ultrasound
FDA device listing 2069519727 · LBN Medical ApS
Key facts
| Proprietary names | Philips Epiq CVx ultrasound |
|---|---|
| Owner/operator | LBN Medical ApS |
| Owner/operator number | 10055731 |
| Premarket submissions | K233788 |
| Product codes | ITX, IYN, IYO, OBJ, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, OBJ - Catheter, Ultrasound, Intravascular, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1200, 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Cardiovascular, 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
- 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