K253446
- 510(k) number
- K253446
- Device name
- AeroDR TX c02
- Applicant
- Dk Medical Systems Co., Ltd. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2026-04-10
- Date received
- 2025-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253446.pdf
Official FDA record: K253446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.