Senographe Pristina
K-Number: K162268 · 2016-11-03
ApplicantGE Healthcare
Decision Date2016-11-03
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 2016-11-03 under approval number K162268. 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 2016-11-03. It is manufactured by GE Healthcare. The 510(k) number is K162268.
When was Senographe Pristina approved by the FDA?
Senographe Pristina received FDA 510(k) clearance on 2016-11-03, under approval number K162268.
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.