Kubtec Xpert 20
by Kubtec
Kubtec Xpert 20 is a tissue specimen x-ray system IVD (FDA Class II; FDA product code KPR, System, X-Ray, Stationary) made by Kubtec, cleared under FDA 510(k) K083510 on 8 Jan 2009 and listed in FDA GUDID since 22 Dec 2017 (UDI-DI B619X200), 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 | NumberB619X200 | Date22 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083510 | Date8 Jan 2009 | StatusActive |
Official records
- FDA 510(k) database K083510
Across registries
- FDA 510(k) K083510 decided 8 Jan 2009 Active
- FDA GUDID UDI-DI B619X200 listed 22 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K083510
- Listed FDA GUDID B619X200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kubtec
- Generic name
- Tissue specimen x-ray system IVD
- Model / reference
- XPERT 20
- Primary DI / UDI-DI
- B619X200
- 510(k) Number
- FDA product code
- KPR
- GMDN term
- Tissue specimen x-ray system IVD
- Device class
- Class II
- Regulation number
- 892.1680
- GUDID distribution status
- In Commercial Distribution
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