K241996
- 510(k) number
- K241996
- Device name
- ULTRA 1040
- Applicant
- Ecoray Co., Ltd. KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2025-04-18
- Date received
- 2024-07-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K241996.pdf
Official FDA record: K241996
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.