BONX805
510(k) K243864
BONX805 is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by BONTECH Co., Ltd., cleared under FDA 510(k) K243864 on 12 Sep 2025, 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 | NumberK243864 | Date12 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K243864
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- Withdrawn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
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