Senographe Pristina
K-Number: K163302 · 2017-09-01
ApplicantGE Healthcare
Decision Date2017-09-01
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Senographe Pristina is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2017-09-01 under approval number K163302. 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 Senographe Pristina?
Senographe Pristina is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by GE Healthcare. The 510(k) number is K163302.
When was Senographe Pristina approved by the FDA?
Senographe Pristina received FDA 510(k) clearance on 2017-09-01, under approval number K163302.
What company makes Senographe Pristina?
Senographe Pristina is manufactured by GE Healthcare.
What is the FDA product code for Senographe Pristina?
The FDA product code for Senographe Pristina is 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.