FDA device listing
AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite
FDA device listing 1906881419 · Samsung Electronics Co., Ltd.
Key facts
| Proprietary names | AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite |
|---|---|
| Owner/operator | Samsung Electronics Co., Ltd. |
| Owner/operator number | 10043488 |
| Premarket submissions | K242651 |
| Product codes | IZL |
| Device names | IZL - System, X-Ray, Mobile |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1720 |
| Review panels | Radiology |
| Registered establishments | Samsung Electronics Co., Ltd., SAMSUNG ELECTRONICS CO., LTD. |
| Establishment registrations | 3010300212, 3032116890 |
| FEI numbers | 3010300212, 3032116890 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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