FDA device listing
660HD Image Management System,KIT US 660HD-E IMS
FDA device listing 1494553864 · Smith & Nephew, Inc.
Key facts
| Proprietary names | 660HD Image Management System,KIT US 660HD-E IMS |
|---|---|
| Owner/operator | Smith & Nephew, Inc. |
| Owner/operator number | 1020279 |
| Product codes | LMB |
| Device names | LMB - Device, Digital Image Storage, Radiological |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.2010 |
| Review panels | Radiology |
| Registered establishments | SMITH & NEPHEW INC. |
| Establishment registrations | 1643264, 3003604053 |
| FEI numbers | 1643264, 3003604053 |
| Establishment operations | Manufacturer, Specification Developer |
| 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