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FDA 510(k)

DeepFoqus (DeepFoqus-Accelerate)

K-Number: K241982 · 2025-04-04

ApplicantFoqus Technologies, Inc.
Decision Date2025-04-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DeepFoqus (DeepFoqus-Accelerate) is a medical device manufactured by Foqus Technologies, Inc.. It received FDA 510(k) clearance on 2025-04-04 under approval number K241982. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepFoqus (DeepFoqus-Accelerate)?

DeepFoqus (DeepFoqus-Accelerate) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Foqus Technologies, Inc.. The 510(k) number is K241982.

When was DeepFoqus (DeepFoqus-Accelerate) approved by the FDA?

DeepFoqus (DeepFoqus-Accelerate) received FDA 510(k) clearance on 2025-04-04, under approval number K241982.

What company makes DeepFoqus (DeepFoqus-Accelerate)?

DeepFoqus (DeepFoqus-Accelerate) is manufactured by Foqus Technologies, Inc..

What is the FDA product code for DeepFoqus (DeepFoqus-Accelerate)?

The FDA product code for DeepFoqus (DeepFoqus-Accelerate) is QIH.

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Official Source

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