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FDA 510(k)

Transpara

K-Number: K181704 · 2018-11-21

ApplicantScreenpoint Medical B.V.
Decision Date2018-11-21
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Transpara is a medical device manufactured by Screenpoint Medical B.V.. It received FDA 510(k) clearance on 2018-11-21 under approval number K181704. 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?

Transpara is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Screenpoint Medical B.V.. The 510(k) number is K181704.

When was Transpara approved by the FDA?

Transpara received FDA 510(k) clearance on 2018-11-21, under approval number K181704.

What company makes Transpara?

Transpara is manufactured by Screenpoint Medical B.V..

What is the FDA product code for Transpara?

The FDA product code for Transpara is QDQ.

Other Devices by Screenpoint Medical B.V.

K192287Transpara K193229Transpara K210404Transpara 1.7.0 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. K192287TransparaScreenpoint Medical B.V. K191994ProFound AI Software V2.1Icad, Inc. K201019Genius AI DetectionHologic, Inc. K192854MammoScreenTherapixel K193229TransparaScreenpoint Medical B.V.

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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