DRE Duo— 510(k) K260482
Substantially EquivalentJpi Healthcare Co, Ltd.
FDA 510(k) clearance K260482 for DRE Duo, Substantially Equivalent on 2026-06-15. Applicant: Jpi Healthcare Co, Ltd.. Device class: 2.
Summary
DRE Duo from Jpi Healthcare is filed under KPR, stationary x-ray systems. The record doesn't expand the name or describe the system beyond the code name.
Class II, 21 CFR 892.1680. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Jpi Healthcare filed from Seoul, South Korea. The decision came 122 calendar days after receipt (February 13 to June 15, 2026).
Clearance details
- Applicant
- Jpi Healthcare Co, Ltd.
- Product code
- Product code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code KPR
view all- K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
- K260488 — MULTIX Impact; MULTIX Impact C
- K260481 — GC85A
- K253446 — AeroDR TX c02
- K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
More clearances from Jpi Healthcare Co, Ltd.
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.