FDA device listing
IRISeg
FDA device listing 1550977271 · Intuitive Surgical, Inc.
Key facts
| Proprietary names | IRISeg |
|---|---|
| Owner/operator | Intuitive Surgical, Inc. |
| Owner/operator number | 9028901 |
| Premarket submissions | K242461 |
| Product codes | LLZ, QIH |
| Device names | LLZ - System, Image Processing, Radiological, QIH - Automated Radiological Image Processing Software |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.2050 |
| Review panels | Radiology |
| Registered establishments | Bio Analitica Argentina S.A., Cyber Robotic Solutions, S.A de C.V., Device Technologies Australia, DSV Solutions LTD., EXPEDITORS, Expeditors International BV, INTUITIVE SURGICAL, INC., Meditec Venezuela C.A. |
| Establishment registrations | 3001675293, 3005369776, 3010157088, 3010885402, 3011063460, 3013868968, 3015612252, 3016832577, 3020331900, 3042940623 |
| FEI numbers | 3001675293, 3005369776, 3010157088, 3010885402, 3011063460, 3013868968, 3015612252, 3016832577, 3020331900, 3042940623 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 10–99 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 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