Pedra 1417FC
Pedra 1417FC (PEDRA-1417FC) is a Class II device made by Radisen Co., Ltd., cleared under FDA 510(k) K221144 on 13 May 2022 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 08800099500038), 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 | Number08800099500038 | Date15 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221144 | Date13 May 2022 | StatusActive |
Official records
- AccessGUDID record 08800099500038
- FDA 510(k) database K221144
Across registries
- FDA 510(k) K221144 decided 13 May 2022 Active
- FDA GUDID UDI-DI 08800099500038 listed 15 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K221144
- Listed FDA GUDID 08800099500038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pedra
- Generic name
- Indirect flat panel x-ray detector
- Model / Ref / Catalog
- 1417FC, PEDRA-1417FC
- Primary DI / UDI-DI
- 08800099500038
- 510(k) Number
- FDA product code
- MQB
- GMDN term
- Indirect flat panel x-ray detector
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Indirect flat panel x-ray detector.