FDA 510(k)

B-Scan

K 號：K243227 · 2025-07-11

申請人Accutome, Inc. Doing Business AS Keeler USA

決定日期2025-07-11

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

B-Scan is the device name listed in this FDA 510(k) record. The listed applicant is Accutome, Inc. Doing Business AS Keeler USA. It received FDA 510(k) clearance on 2025-07-11 under 510(k) number K243227. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the B-Scan?

B-Scan is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Accutome, Inc. Doing Business AS Keeler USA. The 510(k) number is K243227.

When did B-Scan receive FDA 510(k) clearance?

B-Scan received FDA 510(k) clearance on 2025-07-11, under 510(k) number K243227.

Who is the listed applicant for B-Scan?

The FDA 510(k) record lists Accutome, Inc. Doing Business AS Keeler USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-Scan?

The FDA product code for B-Scan is IYO.

相關器械（代碼：IYO）

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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