Radlink Laser Pro 16 LP100
Radlink Laser Pro 16 LP100 is a Class II device made by Radlink, Inc., cleared under FDA 510(k) K020243 on 5 Mar 2002 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00866389000167), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00866389000167 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020243 | Date5 Mar 2002 | StatusActive |
Official records
- AccessGUDID record 00866389000167
- FDA 510(k) database K020243
Across registries
- FDA 510(k) K020243 decided 5 Mar 2002 Active
- FDA GUDID UDI-DI 00866389000167 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K020243
- Listed FDA GUDID 00866389000167
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Radlink Laser Pro 16
- Generic name
- Radiography digital imaging scanner
- Model / reference
- LP100
- Primary DI / UDI-DI
- 00866389000167
- 510(k) Number
- FDA product code
- LMA
- GMDN term
- Radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 892.2030
- GUDID distribution status
- In Commercial Distribution
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