FDA 510(k)

Swoop 隨身式磁共振成像系統

K 號：K221393 · 2022-06-10

決定日期2022-06-10

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 2022-06-10 under 510(k) number K221393. 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 2022-06-10. The listed applicant is Hyperfine, Inc.. The 510(k) number is K221393.

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

Swoop Portable MR Imaging System received FDA 510(k) clearance on 2022-06-10, under 510(k) number K221393.

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®

查看所有 14 項裝置 →

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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