DRE Duo
FDA 510(k) clearance K260482 · decided 2026-06-15
Clearance details
- K-number
- K260482
- Device name
- DRE Duo
- Applicant
- Jpi Healthcare Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-13
- Decision date
- 2026-06-15
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.