FDA device listing
Affiniti Series Diagnostic Ultrasound System,EPIQ Inspira Series Diagnostic Ultrasound System
FDA device listing 1466711921 · Philips Medical Systems International BV
Key facts
| Proprietary names | Affiniti Series Diagnostic Ultrasound System,EPIQ Inspira Series Diagnostic Ultrasound System |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K262548 |
| Product codes | ITX, IYN, IYO, LLZ, OBJ, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, LLZ - System, Image Processing, Radiological, 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 Ultrasound LLC |
| Establishment registrations | 2518586, 3019216 |
| FEI numbers | 2518586, 3019216 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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