SenoBright HD
K-Number: K172404 · 2017-10-30
ApplicantGE Healthcare
Decision Date2017-10-30
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SenoBright HD is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2017-10-30 under approval number K172404. 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 SenoBright HD?
SenoBright HD is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by GE Healthcare. The 510(k) number is K172404.
When was SenoBright HD approved by the FDA?
SenoBright HD received FDA 510(k) clearance on 2017-10-30, under approval number K172404.
What company makes SenoBright HD?
SenoBright HD is manufactured by GE Healthcare.
What is the FDA product code for SenoBright HD?
The FDA product code for SenoBright HD 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.