Kubtec KUB250
by Kubtec
Kubtec KUB250 is a mobile basic diagnostic x-ray system (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Kubtec, cleared under FDA 510(k) K141539 on 29 Oct 2014 and listed in FDA GUDID since 22 Dec 2017 (UDI-DI B619KUB2500), 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 | NumberB619KUB2500 | Date22 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141539 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K141539
Across registries
- FDA 510(k) K141539 decided 29 Oct 2014 Active
- FDA GUDID UDI-DI B619KUB2500 listed 22 Dec 2017 Listed
Timeline
- Cleared FDA 510(k) K141539
- Listed FDA GUDID B619KUB2500
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Kubtec
- Generic name
- Mobile basic diagnostic x-ray system, digital
- Model / reference
- KUB250
- Primary DI / UDI-DI
- B619KUB2500
- 510(k) Number
- FDA product code
- IZL
- GMDN term
- Mobile basic diagnostic x-ray system, digital
- Device class
- Class II
- Regulation number
- 892.1720
- GUDID distribution status
- In Commercial Distribution
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