XPERT80L Xpert 80l
by Kubtec
XPERT80L Xpert 80l is a tissue specimen x-ray system IVD (FDA Class II; FDA product code MWP, Cabinet,X-Ray System) made by Kubtec, cleared under FDA 510(k) K071233 on 20 Jun 2007 and listed in FDA GUDID since 26 Mar 2025 (UDI-DI B619X80LAR0), 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 | NumberB619X80LAR0 | Date26 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071233 | Date20 Jun 2007 | StatusActive |
Official records
- FDA 510(k) database K071233
Across registries
- FDA 510(k) K071233 decided 20 Jun 2007 Active
- FDA GUDID UDI-DI B619X80LAR0 listed 26 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K071233
- Listed FDA GUDID B619X80LAR0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- XPERT80L
- Generic name
- Tissue specimen x-ray system IVD
- Model / reference
- XPERT 80L
- Primary DI / UDI-DI
- B619X80LAR0
- FDA product code
- MWP
- 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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