Pedra 17F
Pedra 17F (PEDRA-17F) is a Class II device made by Radisen Co., Ltd., cleared under FDA 510(k) K180989 on 13 Jun 2018 and listed in FDA GUDID since 15 Nov 2023 (UDI-DI 08800099500007), 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 | Number08800099500007 | Date15 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180989 | Date13 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 08800099500007
- FDA 510(k) database K180989
Across registries
- FDA 510(k) K180989 decided 13 Jun 2018 Active
- FDA GUDID UDI-DI 08800099500007 listed 15 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K180989
- Listed FDA GUDID 08800099500007
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- Withdrawn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
- 17F, PEDRA-17F
- Primary DI / UDI-DI
- 08800099500007
- 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.