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FDA 510(k)

Transpara 1.7.0

K-Number: K210404 · 2021-06-02

ApplicantScreenpoint Medical B.V.
Decision Date2021-06-02
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Transpara 1.7.0 is a medical device manufactured by Screenpoint Medical B.V.. It received FDA 510(k) clearance on 2021-06-02 under approval number K210404. 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 1.7.0?

Transpara 1.7.0 is a medical device that received FDA 510(k) clearance on 2021-06-02. It is manufactured by Screenpoint Medical B.V.. The 510(k) number is K210404.

When was Transpara 1.7.0 approved by the FDA?

Transpara 1.7.0 received FDA 510(k) clearance on 2021-06-02, under approval number K210404.

What company makes Transpara 1.7.0?

Transpara 1.7.0 is manufactured by Screenpoint Medical B.V..

What is the FDA product code for Transpara 1.7.0?

The FDA product code for Transpara 1.7.0 is QDQ.

Other Devices by Screenpoint Medical B.V.

K181704Transpara K192287Transpara K193229Transpara K221347Transpara 1.7.2 K232096Transpara Density 1.0.0 K241831Transpara (2.1.0)

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Related Devices (Code: QDQ)

K182373PowerLook Tomo Detection V2 SoftwareIcad, Inc. K181704TransparaScreenpoint Medical B.V. K192287TransparaScreenpoint Medical B.V. K191994ProFound AI Software V2.1Icad, Inc. K201019Genius AI DetectionHologic, Inc. K192854MammoScreenTherapixel

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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