FDA 510(k)

DIANA

K-Number: K260192 · 2026-07-24

Decision Date2026-07-24

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DIANA is the device name listed in this FDA 510(k) record. The listed applicant is ROPCA ApS. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K260192. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIANA?

DIANA is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is ROPCA ApS. The 510(k) number is K260192.

When did DIANA receive FDA 510(k) clearance?

DIANA received FDA 510(k) clearance on 2026-07-24, under 510(k) number K260192.

Who is the listed applicant for DIANA?

The FDA 510(k) record lists ROPCA ApS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIANA?

The FDA product code for DIANA is QIH.

Other records listing ROPCA ApS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260190ARTHUR

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.