FDA device listing
EPIQ 5 Circular Edition Ultrasound System,EPIQ 5 Diamond Select Ultrasound System,EPIQ 5 Ultrasound System,EPIQ 5W…
FDA device listing 1465817488 · Philips Medical Systems International BV
Key facts
| Proprietary names | EPIQ 5 Circular Edition Ultrasound System,EPIQ 5 Diamond Select Ultrasound System,EPIQ 5 Ultrasound System,EPIQ 5W Ultrasound System,EPIQ 7 Circular Edition Ultrasound System,EPIQ 7 Diamond Select Ultrasound System,EPIQ 7 Ultrasound System,EPIQ 7W Ultrasound System,EPIQ CVx Circular Edition Ultrasound System,EPIQ CVxi Ultrasound System,EPIQ CVx Ultrasound System,EPIQ Elite Circular Edition… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K231190 |
| 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 | Philips Electronics Ltd, Philips Ultrasound LLC, Philips Ultrasound (Shanghai) Co., Ltd |
| Establishment registrations | 3019216, 3000126629, 3005403518, 3017894900 |
| FEI numbers | 3019216, 3000126629, 3005403518, 3017894900 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract 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