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FDA 510(k)

OR頭架 LUCY 配 HeadCoilSet 西門子 1.5T，OR頭架 LUCY 配 HeadCoilSet 西門子 3T，OR頭架 LUCY 配 HeadCoilSet 飛利浦 1.5T，OR頭架 LUCY 配 HeadCoilSet 飛利浦 3T

K 號：K211658 · 2022-03-03

申請人Noras Mri Products GmbH
決定日期2022-03-03
產品代碼MOS
諮詢委員會RA
決定相當於

器材摘要

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T is the device name listed in this FDA 510(k) record. The listed applicant is Noras Mri Products GmbH. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K211658. 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 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T?

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Noras Mri Products GmbH. The 510(k) number is K211658.

When did OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T receive FDA 510(k) clearance?

OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T received FDA 510(k) clearance on 2022-03-03, under 510(k) number K211658.

Who is the listed applicant for OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T?

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

What is the FDA product code for OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T?

The FDA product code for OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T is MOS.

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其他以 Noras Mri Products GmbH 為申請人之記錄

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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相關器械（代碼：MOS）

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官方來源

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