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FDA 510(k)

DeepFoqus (DeepFoqus-Accelerate)

K 號：K241982 · 2025-04-04

申請人Foqus Technologies, Inc.
決定日期2025-04-04
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

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

常見問題

What is the DeepFoqus (DeepFoqus-Accelerate)?

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

When did DeepFoqus (DeepFoqus-Accelerate) receive FDA 510(k) clearance?

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

Who is the listed applicant for DeepFoqus (DeepFoqus-Accelerate)?

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

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

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

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官方來源

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