FDA device listing
12L5A Linear Array Transducer,4V2A Sector Transducer,5C2A Curved Linear Array Transducer,8EC4A Curved Array…
FDA device listing 1485816841 · Philips Medical Systems International BV
Key facts
| Proprietary names | 12L5A Linear Array Transducer,4V2A Sector Transducer,5C2A Curved Linear Array Transducer,8EC4A Curved Array Transducer,8V3A Sector Transducer,9MC3 Curved Array Transducer |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K150533 |
| 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 Ultrasound LLC |
| Establishment registrations | 3019216, 3000126629 |
| FEI numbers | 3019216, 3000126629 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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