Esteya 187001
Esteya 187001 is a skin-tumour low-voltage therapeutic x-ray system (FDA Class II; FDA product code JAD, System, therapeutic, x-ray) made by Nucletron B.V., cleared under FDA 510(k) K132092 on 26 Sep 2013 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 08717213036086), 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 | Number08717213036086 | Date28 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132092 | Date26 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 08717213036086
- FDA 510(k) database K132092
Across registries
- FDA 510(k) K132092 decided 26 Sep 2013 Active
- FDA GUDID UDI-DI 08717213036086 listed 28 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K132092
- Listed FDA GUDID 08717213036086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Esteya
- Generic name
- Skin-tumour low-voltage therapeutic x-ray system
- Model / reference
- 187001
- Primary DI / UDI-DI
- 08717213036086
- 510(k) Number
- FDA product code
- JAD
- GMDN term
- Skin-tumour low-voltage therapeutic x-ray system
- Device class
- Class II
- Regulation number
- 892.5900
- GUDID distribution status
- In Commercial Distribution
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