3D/5D Viewer
510(k) K151808
3D/5D Viewer is a Class II device made by Samsung Medison Co., Ltd., cleared under FDA 510(k) K151808 on 29 Jul 2015, active as of 24 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151808 | Date29 Jul 2015 | StatusActive |
Official records
- FDA 510(k) database K151808
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151808
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 3D/5D VIEWER USO-U0NMI00/WR | USO-U0NMI00/WR | 08806167754969 | — | On the market |
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