FDA 510(k)

Swoop® 輕便式磁共振成像系統™

K 號：K230208 · 2023-02-22

決定日期2023-02-22

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Swoop® Portable MR Imaging System™ is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine, Inc.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K230208. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Swoop® Portable MR Imaging System™?

Swoop® Portable MR Imaging System™ is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Hyperfine, Inc.. The 510(k) number is K230208.

When did Swoop® Portable MR Imaging System™ receive FDA 510(k) clearance?

Swoop® Portable MR Imaging System™ received FDA 510(k) clearance on 2023-02-22, under 510(k) number K230208.

Who is the listed applicant for Swoop® Portable MR Imaging System™?

FDA 510(k) 記錄將 Hyperfine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Swoop® Portable MR Imaging System™?

The FDA product code for Swoop® Portable MR Imaging System™ is LNH.

其他以 Hyperfine, Inc. 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。

K262622Swoop® 輕便式磁共振成像® 系統 K253489Swoop® 輕便式磁共振成像® 系統 K250236Swoop® 輕便式磁共振成像系統® (V2)K251276Swoop® 輕便式磁共振成像® 系統 K240944Swoop® 輕便式磁共振成像® 系統 K232760Swoop® 輕便式核磁共振成像系統®

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相關器械（代碼：LNH）

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。

K261283APERTO Lucent MRI 系統Fujifilm Corporation K261758擁抱視覺新生兒MRI系統Aspect Imaging, Ltd.K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® 輕便式磁共振成像® 系統Hyperfine, Inc.K254250MagicScan-1.5，綠色MR寧靜1.5TXingaoyi Medical Equipment Co.,Ltd K253808空氣偵探 DLGE Medical Systems

官方來源

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