Enduro Dr ES70
Enduro Dr ES70 is a portable basic diagnostic x-ray system (FDA Class II; FDA product code IZI, System, X-Ray, Angiographic) made by Remedi Co., Ltd., cleared under FDA 510(k) K212144 on 3 Aug 2021 and listed in FDA GUDID since 20 Sep 2024 (UDI-DI 08800060100243), 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 | Number08800060100243 | Date20 Sep 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212144 | Date3 Aug 2021 | StatusActive |
Official records
- AccessGUDID record 08800060100243
- FDA 510(k) database K212144
Across registries
- FDA 510(k) K212144 decided 3 Aug 2021 Active
- FDA GUDID UDI-DI 08800060100243 listed 20 Sep 2024 Listed
Timeline
- Cleared FDA 510(k) K212144
- Listed FDA GUDID 08800060100243
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Enduro Dr
- Generic name
- Portable basic diagnostic x-ray system, digital
- Model / reference
- ES70
- Primary DI / UDI-DI
- 08800060100243
- 510(k) Number
- FDA product code
- IZI
- GMDN term
- Portable basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1600
- GUDID distribution status
- In Commercial Distribution
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