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FDA 510(k)

OncoStudio

K 號：K260528 · 2026-07-02

申請人Oncosoft. Inc.,
決定日期2026-07-02
產品代碼QKB
諮詢委員會RA
決定相當於

器材摘要

OncoStudio is the device name listed in this FDA 510(k) record. The listed applicant is Oncosoft. Inc.,. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260528. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OncoStudio?

OncoStudio is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Oncosoft. Inc.,. The 510(k) number is K260528.

When did OncoStudio receive FDA 510(k) clearance?

OncoStudio received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260528.

Who is the listed applicant for OncoStudio?

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

What is the FDA product code for OncoStudio?

The FDA product code for OncoStudio is QKB.

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相關器械（代碼：QKB）

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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