FDA 510(k)

InVision™ 3T Recharge Operating Suite

Número K: K252239 · 2025-08-06

Data da decisão2025-08-06

Código do produtoLNH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

InVision™ 3T Recharge Operating Suite is the device name listed in this FDA 510(k) record. The listed applicant is Imris Imaging, Inc.. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K252239. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Imris Imaging, Inc.. The 510(k) number is K252239.

When did InVision™ 3T Recharge Operating Suite receive FDA 510(k) clearance?

InVision™ 3T Recharge Operating Suite received FDA 510(k) clearance on 2025-08-06, under 510(k) number K252239.

Who is the listed applicant for InVision™ 3T Recharge Operating Suite?

The FDA 510(k) record lists Imris Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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