AlignRT Plus
K-Number: K193431 · 2020-01-03
ApplicantVision Rt, Ltd.
Decision Date2020-01-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AlignRT Plus is a medical device manufactured by Vision Rt, Ltd.. It received FDA 510(k) clearance on 2020-01-03 under approval number K193431. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AlignRT Plus?
AlignRT Plus is a medical device that received FDA 510(k) clearance on 2020-01-03. It is manufactured by Vision Rt, Ltd.. The 510(k) number is K193431.
When was AlignRT Plus approved by the FDA?
AlignRT Plus received FDA 510(k) clearance on 2020-01-03, under approval number K193431.
What company makes AlignRT Plus?
AlignRT Plus is manufactured by Vision Rt, Ltd..
What is the FDA product code for AlignRT Plus?
The FDA product code for AlignRT Plus is IYE.
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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.