Invenia ABUS Viewer
K-Number: K180641 · 2018-05-04
ApplicantGE Healthcare
Decision Date2018-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Invenia ABUS Viewer is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-05-04 under approval number K180641. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Invenia ABUS Viewer?
Invenia ABUS Viewer is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by GE Healthcare. The 510(k) number is K180641.
When was Invenia ABUS Viewer approved by the FDA?
Invenia ABUS Viewer received FDA 510(k) clearance on 2018-05-04, under approval number K180641.
What company makes Invenia ABUS Viewer?
Invenia ABUS Viewer is manufactured by GE Healthcare.
What is the FDA product code for Invenia ABUS Viewer?
The FDA product code for Invenia ABUS Viewer is LLZ.
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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.