FDA 510(k)

Synapse PACS (7.5)

K 號：K243647 · 2025-06-30

申請人FUJIFILM Healthcare Americas Corporation

決定日期2025-06-30

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Synapse PACS (7.5) is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K243647. 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 Synapse PACS (7.5)?

Synapse PACS (7.5) is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K243647.

When did Synapse PACS (7.5) receive FDA 510(k) clearance?

Synapse PACS (7.5) received FDA 510(k) clearance on 2025-06-30, under 510(k) number K243647.

Who is the listed applicant for Synapse PACS (7.5)?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synapse PACS (7.5)?

The FDA product code for Synapse PACS (7.5) is QIH.

其他以 FUJIFILM Healthcare Americas Corporation 為申請人之記錄

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相關器械（代碼：QIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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