Remex KA6
510(k) K212144
Remex KA6 is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Remedi Co., Ltd., cleared under FDA 510(k) K212144 on 3 Aug 2021, 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 | FDA 510(k)SESE | NumberK212144 | Date3 Aug 2021 | StatusActive |
Official records
- FDA 510(k) database K212144
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K212144
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ENDORO DR ES70 X-ray Source | ES70 | 08800060100236 | — | On the market |
| ENDURO DR ES70 | ES70 | 08800060100243 | — | On the market |
| REMEX KA6 | REMEX KA6 | 08800060100151 | — | On the market |
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