K253058
- 510(k) number
- K253058
- Device name
- Portable DR Imaging System
- Applicant
- Shantou Institute of Ultrasonic Instruments Co., Ltd. CN
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2026-06-18
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253058.pdf
Official FDA record: K253058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.