FDA device listing
APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
FDA device listing 1461311141 · CANON INC.
Key facts
| Proprietary names | APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) |
|---|---|
| Owner/operator | CANON INC. |
| Owner/operator number | 8030410 |
| Premarket submissions | K241582 |
| Product codes | ITX, IYN, IYO, QIH |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | CANON INC. |
| Establishment registrations | 9614698, 3012761544 |
| FEI numbers | 3002808382, 3012761544 |
| Establishment operations | 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