K251223
- 510(k) number
- K251223
- Device name
- HnX-P1, HnX-PB
- Applicant
- H&abyz Co., Ltd. KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2025-08-04
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251223.pdf
Official FDA record: K251223
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.