FDA device listing
Affiniti 30 Circular Edition Ultrasound System,Affiniti 30 Diamond Select Ultrasound System,Affiniti 30 Ultrasound…
FDA device listing 1344587417 · Philips Medical Systems International BV
Key facts
| Proprietary names | Affiniti 30 Circular Edition Ultrasound System,Affiniti 30 Diamond Select Ultrasound System,Affiniti 30 Ultrasound System,Affiniti 50 Circular Edition Ultrasound System,Affiniti 50 Diamond Select Ultrasound System,Affiniti 50 Ultrasound System,Affiniti 70 Circular Edition Ultrasound System,Affiniti 70 Diamond Select Ultrasound System,Affiniti 70 Ultrasound System,Affiniti CVx Ultrasound… |
|---|---|
| Owner/operator | Philips Medical Systems International BV |
| Owner/operator number | 1217116 |
| Premarket submissions | K211597 |
| 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 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
- 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