K260482
- 510(k) number
- K260482
- Device name
- DRE Duo
- Applicant
- Jpi Healthcare Co, Ltd. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2026-06-15
- Date received
- 2026-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260482.pdf
Official FDA record: K260482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.