DIANA— 510(k) K260192
Substantially EquivalentROPCA ApS
FDA 510(k) clearance K260192 for DIANA, Substantially Equivalent on 2026-07-24. Applicant: ROPCA ApS. Device class: 2.
Summary
DIANA from ROPCA is filed under QIH, automated radiological image processing software. The name is an unexpanded word or acronym, and the record doesn't describe what the software processes.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
ROPCA filed from Odense M, Denmark. The decision came 183 calendar days after FDA received it (January 22 to July 24, 2026).
Clearance details
- Applicant
- ROPCA ApS
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Odense M, DK
Recent devices under product code QIH
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