GSI Viewer with GSI Fat Option
K-Number: K180225 · 2018-04-24
ApplicantGE Medical Systems SCS
Decision Date2018-04-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
GSI Viewer with GSI Fat Option is a medical device manufactured by GE Medical Systems SCS. It received FDA 510(k) clearance on 2018-04-24 under approval number K180225. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GSI Viewer with GSI Fat Option?
GSI Viewer with GSI Fat Option is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by GE Medical Systems SCS. The 510(k) number is K180225.
When was GSI Viewer with GSI Fat Option approved by the FDA?
GSI Viewer with GSI Fat Option received FDA 510(k) clearance on 2018-04-24, under approval number K180225.
What company makes GSI Viewer with GSI Fat Option?
GSI Viewer with GSI Fat Option is manufactured by GE Medical Systems SCS.
What is the FDA product code for GSI Viewer with GSI Fat Option?
The FDA product code for GSI Viewer with GSI Fat Option is JAK.
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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.