FDA device listing
DBS-57M,LLD 129 Basic,LLD 129 Compact,LLD 129 Samsung,LLD 129 without rotation,LLD 129 with rotation,LLD 86 Basic
FDA device listing 2058595082 · DRTECH CORPORATION
Key facts
| Proprietary names | DBS-57M,LLD 129 Basic,LLD 129 Compact,LLD 129 Samsung,LLD 129 without rotation,LLD 129 with rotation,LLD 86 Basic |
|---|---|
| Owner/operator | DRTECH CORPORATION |
| Owner/operator number | 9073399 |
| Product codes | IXY |
| Device names | IXY - Holder, Radiographic Cassette, Wall-Mounted |
| Device class | Class I |
| Classification regulations (21 CFR) | 892.1880 |
| Review panels | Radiology |
| Registered establishments | DRTECH Corporation |
| Establishment registrations | 3005172103 |
| FEI numbers | 3005172103 |
| Establishment operations | 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