FDA device listing
Ventripoint Medical System Plus (Vms+) 3.0
FDA device listing 1911079152 · Ventripoint Diagnostics Ltd.
Key facts
| Proprietary names | Ventripoint Medical System Plus (Vms+) 3.0 |
|---|---|
| Owner/operator | Ventripoint Diagnostics Ltd. |
| Owner/operator number | 10046630 |
| Premarket submissions | K191493 |
| Product codes | ITX, IYN, IYO, LLZ |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYN - System, Imaging, Pulsed Doppler, Ultrasonic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, LLZ - System, Image Processing, Radiological |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1550, 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | VENTRIPOINT DIAGNOSTICS LTD. |
| Establishment registrations | 3007194257 |
| FEI numbers | 3007194257 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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