InVision 3T Recharge Operating Suite
K-Number: K252239 · 2025-08-06
ApplicantImris Imaging, Inc.
Decision Date2025-08-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
InVision 3T Recharge Operating Suite is a medical device manufactured by Imris Imaging, Inc.. It received FDA 510(k) clearance on 2025-08-06 under approval number K252239. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the InVision 3T Recharge Operating Suite?
InVision 3T Recharge Operating Suite is a medical device that received FDA 510(k) clearance on 2025-08-06. It is manufactured by Imris Imaging, Inc.. The 510(k) number is K252239.
When was InVision 3T Recharge Operating Suite approved by the FDA?
InVision 3T Recharge Operating Suite received FDA 510(k) clearance on 2025-08-06, under approval number K252239.
What company makes InVision 3T Recharge Operating Suite?
InVision 3T Recharge Operating Suite is manufactured by Imris Imaging, Inc..
What is the FDA product code for InVision 3T Recharge Operating Suite?
The FDA product code for InVision 3T Recharge Operating Suite is LNH.
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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.