APELEM PLATINUM dRF (8L)
by Apelem
APELEM PLATINUM dRF (8L) is a Class II device made by Apelem, cleared under FDA 510(k) K203010 on 22 Jan 2021 and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 03760172650447), active as of 23 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 | Number03760172650447 | Date7 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203010 | Date22 Jan 2021 | StatusActive |
Official records
- AccessGUDID record 03760172650447
- FDA 510(k) database K203010
Across registries
- FDA 510(k) K203010 decided 22 Jan 2021 Active
- FDA GUDID UDI-DI 03760172650447 listed 7 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K203010
- Listed FDA GUDID 03760172650447
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apelem
- Generic name
- Basic diagnostic x-ray system table, powered
- Model / reference
- PLATINUM dRF (8L)
- Primary DI / UDI-DI
- 03760172650447
- 510(k) Number
- FDA product code
- JAA
- GMDN term
- Basic diagnostic x-ray system table, powered
- Device class
- Class II
- Regulation number
- 892.1650
- GUDID distribution status
- In Commercial Distribution
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