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.
Clearance details
- Applicant
- Jpi Healthcare Co, Ltd.
- Product code
- 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.