FDA 510(k)

無限特 DPS

K 號：K243449 · 2025-12-09

決定日期2025-12-09

產品代碼QKQ

諮詢委員會PA

決定相當於

器材摘要

INFINITT DPS is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) number K243449. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the INFINITT DPS?

INFINITT DPS is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Infinitt Healthcare Co., Ltd.. The 510(k) number is K243449.

When did INFINITT DPS receive FDA 510(k) clearance?

INFINITT DPS received FDA 510(k) clearance on 2025-12-09, under 510(k) number K243449.

Who is the listed applicant for INFINITT DPS?

The FDA 510(k) record lists Infinitt Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITT DPS?

The FDA product code for INFINITT DPS is QKQ.

其他以 Infinitt Healthcare Co., Ltd. 為申請人之記錄

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。

K193369Xelis牙科2.0 K193498無限通RT PACS K172803Infinitt PACS 7.0

相關器械（代碼：QKQ）

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。

K261380Concentriq AP-DxProscia, Inc.K252762HALO AP DxIndica Labs, LLC K243391AISight DxPathAI, Inc.K250968PathPresenter 醫療設備規範文本 PathPresenter 醫療影像檢視器Pathpresenter Corporation K250414CaloPixTribun Health K242244觀眾+Lumea, Inc.

官方來源

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