K250790
- 510(k) number
- K250790
- Device name
- INNOVISION-DXII
- Applicant
- Dk Medical Systems Co., Ltd. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-08-01
- Date received
- 2025-03-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250790.pdf
Official FDA record: K250790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.