FDA 510(k)

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil

K 號：K181948 · 2018-11-16

決定日期2018-11-16

產品代碼MOS

諮詢委員會RA

決定相當於

器材摘要

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Biomedical GmbH. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181948. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Rapid Biomedical GmbH. The 510(k) number is K181948.

When did 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil receive FDA 510(k) clearance?

1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181948.

Who is the listed applicant for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

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

What is the FDA product code for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil?

The FDA product code for 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil is MOS.

其他以 Rapid Biomedical GmbH 為申請人之記錄

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相關器械（代碼：MOS）

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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