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FDA 510(k)

Sample Imaging for Senographe Pristina

K-Number: K190809 · 2019-07-29

ApplicantGE Healthcare
Decision Date2019-07-29
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sample Imaging for Senographe Pristina is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2019-07-29 under approval number K190809. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sample Imaging for Senographe Pristina?

Sample Imaging for Senographe Pristina is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by GE Healthcare. The 510(k) number is K190809.

When was Sample Imaging for Senographe Pristina approved by the FDA?

Sample Imaging for Senographe Pristina received FDA 510(k) clearance on 2019-07-29, under approval number K190809.

What company makes Sample Imaging for Senographe Pristina?

Sample Imaging for Senographe Pristina is manufactured by GE Healthcare.

What is the FDA product code for Sample Imaging for Senographe Pristina?

The FDA product code for Sample Imaging for Senographe Pristina is MUE.

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Related Devices (Code: MUE)

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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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