FDA 510(k)

Aquilion ONE (TSX-308A/TSX-306A) V2.0

K 號：K253596 · 2026-05-20

決定日期2026-05-20

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Aquilion ONE (TSX-308A/TSX-306A) V2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K253596. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aquilion ONE (TSX-308A/TSX-306A) V2.0?

Aquilion ONE (TSX-308A/TSX-306A) V2.0 is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K253596.

When did Aquilion ONE (TSX-308A/TSX-306A) V2.0 receive FDA 510(k) clearance?

Aquilion ONE (TSX-308A/TSX-306A) V2.0 received FDA 510(k) clearance on 2026-05-20, under 510(k) number K253596.

Who is the listed applicant for Aquilion ONE (TSX-308A/TSX-306A) V2.0?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilion ONE (TSX-308A/TSX-306A) V2.0?

The FDA product code for Aquilion ONE (TSX-308A/TSX-306A) V2.0 is JAK.

其他以 Canon Medical Systems Corporation 為申請人之記錄

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相關器械（代碼：JAK）

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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