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FDA 510(k)

Transpara (2.1.0)

K-Number: K260898 · 2026-08-14

ApplicantScreenpoint Medical B.V.
Decision Date2026-08-14
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Transpara (2.1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Screenpoint Medical B.V.. It received FDA 510(k) clearance on 2026-08-14 under 510(k) number K260898. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transpara (2.1.0)?

Transpara (2.1.0) is a medical device that received FDA 510(k) clearance on 2026-08-14. The listed applicant is Screenpoint Medical B.V.. The 510(k) number is K260898.

When did Transpara (2.1.0) receive FDA 510(k) clearance?

Transpara (2.1.0) received FDA 510(k) clearance on 2026-08-14, under 510(k) number K260898.

Who is the listed applicant for Transpara (2.1.0)?

The FDA 510(k) record lists Screenpoint Medical B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transpara (2.1.0)?

The FDA product code for Transpara (2.1.0) is QDQ.

Other records listing Screenpoint Medical B.V. 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.

K241831Transpara (2.1.0)K232096Transpara Density 1.0.0K221347Transpara 1.7.2K210404Transpara 1.7.0K193229TransparaK192287Transpara

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Related Devices (Code: QDQ)

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.

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Official Source

View on FDA Database →

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

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