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FDA 510(k)

CCI PACS 觀看器 (PACS-US-001)

K 號：K254237 · 2026-04-23

申請人CliniComp, Intl.
決定日期2026-04-23
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

CCI PACS VIEWER (PACS-US-001) is the device name listed in this FDA 510(k) record. The listed applicant is CliniComp, Intl.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K254237. 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 CCI PACS VIEWER (PACS-US-001)?

CCI PACS VIEWER (PACS-US-001) is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is CliniComp, Intl.. The 510(k) number is K254237.

When did CCI PACS VIEWER (PACS-US-001) receive FDA 510(k) clearance?

CCI PACS VIEWER (PACS-US-001) received FDA 510(k) clearance on 2026-04-23, under 510(k) number K254237.

Who is the listed applicant for CCI PACS VIEWER (PACS-US-001)?

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

What is the FDA product code for CCI PACS VIEWER (PACS-US-001)?

The FDA product code for CCI PACS VIEWER (PACS-US-001) is LLZ.

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相關器械（代碼：LLZ）

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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