FDA 510(k)

AGFA HealthCare Enterprise Imaging

K 號：K252199 · 2025-10-15

決定日期2025-10-15

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

AGFA HealthCare Enterprise Imaging is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) number K252199. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AGFA HealthCare Enterprise Imaging?

AGFA HealthCare Enterprise Imaging is a medical device that received FDA 510(k) clearance on 2025-10-15. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K252199.

When did AGFA HealthCare Enterprise Imaging receive FDA 510(k) clearance?

AGFA HealthCare Enterprise Imaging received FDA 510(k) clearance on 2025-10-15, under 510(k) number K252199.

Who is the listed applicant for AGFA HealthCare Enterprise Imaging?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGFA HealthCare Enterprise Imaging?

The FDA product code for AGFA HealthCare Enterprise Imaging is LLZ.

其他以 Agfa Healthcare N.V. 為申請人之記錄

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相關器械（代碼：LLZ）

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