K243864
- 510(k) number
- K243864
- Device name
- BONX805
- Applicant
- Bontech Co., Ltd. KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2025-09-12
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243864.pdf
Official FDA record: K243864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.