FDA 510(k)

呼吸門控掃描器（2.1）

K 號：K253026 · 2026-06-04

決定日期2026-06-04

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

Respiratory Gating for Scanners (2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253026. 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 Respiratory Gating for Scanners (2.1)?

Respiratory Gating for Scanners (2.1) is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K253026.

When did Respiratory Gating for Scanners (2.1) receive FDA 510(k) clearance?

Respiratory Gating for Scanners (2.1) received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253026.

Who is the listed applicant for Respiratory Gating for Scanners (2.1)?

FDA 510(k) 記錄將 Varian Medical Systems, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Respiratory Gating for Scanners (2.1)?

The FDA product code for Respiratory Gating for Scanners (2.1) is JAK.

其他以 Varian Medical Systems, Inc. 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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