FDA device listing
C10-3 MHz Transducer,C5-1 MHz Transducer,Cable, Leadwires, ECG,External ECG Connector Cable and Adapter,IC10-3 MHz…
FDA device listing 1108700126 · FUJIFILM CORPORATION
Key facts
| Proprietary names | C10-3 MHz Transducer,C5-1 MHz Transducer,Cable, Leadwires, ECG,External ECG Connector Cable and Adapter,IC10-3 MHz Transducer,L12-3 MHz Transducer,L15-4 MHz Transducer,L19-5 MHz Transducer,P5-1 MHz Transducer,Sonosite ECG Module,Sonosite ECG Module Leadwires,Sonosite LX Ultrasound System,Sonosite PX Ultrasound System,Sonosite ST Ultrasound System,Sonosite ZX Ultrasound System,T8-3 MHz Transducer |
|---|---|
| Owner/operator | FUJIFILM CORPORATION |
| Owner/operator number | 8031568 |
| Premarket submissions | K213763 |
| Product codes | ITX, IYN, IYO, OIJ |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, OIJ - Biopsy Needle Guide Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570 |
| Review panels | Radiology |
| Registered establishments | FUJIFILM SONOSITE,INC. |
| Establishment registrations | 3032367 |
| FEI numbers | 3002087856 |
| Establishment operations | Complaint File Establishment, Manufacturer, Remanufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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