FDA device listing
iU22 Ultrasound System,L12-5
FDA device listing 1458224401 · Philips Medical Systems International BV
Key facts
| Proprietary names | iU22 Ultrasound System,L12-5 |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K093563 |
| Product codes | ITX, IYN, IYO |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Review panels | Radiology |
| Registered establishments | Philips Electronics Ltd, Philips Global Business Services LLP - Ultrasound Business Unit, Philips India Limited - Ultrasound Business Unit, Philips Ultrasound LLC |
| Establishment registrations | 2518586, 3019216, 3000126629, 3017894900, 3033527241, 3033527283 |
| FEI numbers | 2518586, 3019216, 3000126629, 3017894900, 3033527241, 3033527283 |
| Establishment operations | Complaint File Establishment, Manufacturer, Foreign Exporter, Specification Developer |
| 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