FDA device listing
EPIQ 5C Diagnostic Ultrasound System,EPIQ 5 Circular Edition Ultrasound System,EPIQ 5 Diagnostic Ultrasound System,EPIQ…
FDA device listing 1963741387 · Philips Medical Systems International BV
Key facts
| Proprietary names | EPIQ 5C Diagnostic Ultrasound System,EPIQ 5 Circular Edition Ultrasound System,EPIQ 5 Diagnostic Ultrasound System,EPIQ 5 Diamond Select Ultrasound System,EPIQ 5G Diagnostic Ultrasound System,EPIQ 5W Diagnostic Ultrasound System,EPIQ 7C Diagnostic Ultrasound System,EPIQ 7 Circular Edition Ultrasound System,EPIQ 7 Diagnostic Ultrasound System,EPIQ 7 Diamond Select Ultrasound System,EPIQ 7G… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K233545 |
| 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 Ultrasound LLC |
| Establishment registrations | 2518586, 3019216, 3017894900 |
| FEI numbers | 2518586, 3019216, 3017894900 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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