FDA 510(k)

Bunkerhill 腹部主动脉量化 (AAQ)

K 號：K243779 · 2025-07-01

決定日期2025-07-01

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Bunkerhill Abdominal Aortic Quantification (AAQ) is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K243779. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bunkerhill Abdominal Aortic Quantification (AAQ)?

Bunkerhill Abdominal Aortic Quantification (AAQ) is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is BunkerHill Health. The 510(k) number is K243779.

When did Bunkerhill Abdominal Aortic Quantification (AAQ) receive FDA 510(k) clearance?

Bunkerhill Abdominal Aortic Quantification (AAQ) received FDA 510(k) clearance on 2025-07-01, under 510(k) number K243779.

Who is the listed applicant for Bunkerhill Abdominal Aortic Quantification (AAQ)?

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

What is the FDA product code for Bunkerhill Abdominal Aortic Quantification (AAQ)?

The FDA product code for Bunkerhill Abdominal Aortic Quantification (AAQ) is QIH.

其他以 BunkerHill Health 為申請人之記錄

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相關器械（代碼：QIH）

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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