FDA device listing
iSR'obot Mona Lisa 2.0
FDA device listing 1925034114 · Sys-Mac Automation Engineering Pte LTd
Key facts
| Proprietary names | iSR'obot Mona Lisa 2.0 |
|---|---|
| Owner/operator | Sys-Mac Automation Engineering Pte LTd |
| Owner/operator number | 10091178 |
| Product codes | ITX, IYO, LLZ |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic, IYO - System, Imaging, Pulsed Echo, Ultrasonic, LLZ - System, Image Processing, Radiological |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1560, 892.1570, 892.2050 |
| Review panels | Radiology |
| Registered establishments | SYS-MAC AUTOMATION ENGINEERING PTE LTD |
| Establishment registrations | 3017263724 |
| FEI numbers | 3017263724 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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