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FDA 510(k)

灌流測量平台 v1

K 號:K253421 · 2026-06-22

決定日期2026-06-22
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

Perfusion Measurement Platform v1 is the device name listed in this FDA 510(k) record. The listed applicant is Quantified Imaging Limited. It received FDA 510(k) clearance on 2026-06-22 under 510(k) number K253421. 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 Perfusion Measurement Platform v1?

Perfusion Measurement Platform v1 is a medical device that received FDA 510(k) clearance on 2026-06-22. The listed applicant is Quantified Imaging Limited. The 510(k) number is K253421.

When did Perfusion Measurement Platform v1 receive FDA 510(k) clearance?

Perfusion Measurement Platform v1 received FDA 510(k) clearance on 2026-06-22, under 510(k) number K253421.

Who is the listed applicant for Perfusion Measurement Platform v1?

The FDA 510(k) record lists Quantified Imaging Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perfusion Measurement Platform v1?

The FDA product code for Perfusion Measurement Platform v1 is LLZ.

相關臨床試驗

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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。

官方來源

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