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FDA 510(k)

骨磁共振v1.4

K 號：K221762 · 2022-11-16

申請人Mrlguidance B.V.
決定日期2022-11-16
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

BoneMRI v1.4 is the device name listed in this FDA 510(k) record. The listed applicant is Mrlguidance B.V.. It received FDA 510(k) clearance on 2022-11-16 under 510(k) number K221762. 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 BoneMRI v1.4?

BoneMRI v1.4 is a medical device that received FDA 510(k) clearance on 2022-11-16. The listed applicant is Mrlguidance B.V.. The 510(k) number is K221762.

When did BoneMRI v1.4 receive FDA 510(k) clearance?

BoneMRI v1.4 received FDA 510(k) clearance on 2022-11-16, under 510(k) number K221762.

Who is the listed applicant for BoneMRI v1.4?

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

What is the FDA product code for BoneMRI v1.4?

The FDA product code for BoneMRI v1.4 is QIH.

相關臨床試驗

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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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家VisianaK261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care DiagnosticsK261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLCK2608794DMINVIA, LLC

官方來源

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