FDA 510(k)

MR 5300 及 MR 7700 R11 MR 系統

K 號：K223442 · 2022-12-23

申請人Philips Medical Systems Nederlands B.V.

決定日期2022-12-23

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

MR 5300 and MR 7700 R11 MR Systems is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K223442. 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 MR 5300 and MR 7700 R11 MR Systems?

MR 5300 and MR 7700 R11 MR Systems is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K223442.

When did MR 5300 and MR 7700 R11 MR Systems receive FDA 510(k) clearance?

MR 5300 and MR 7700 R11 MR Systems received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223442.

Who is the listed applicant for MR 5300 and MR 7700 R11 MR Systems?

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

What is the FDA product code for MR 5300 and MR 7700 R11 MR Systems?

The FDA product code for MR 5300 and MR 7700 R11 MR Systems is LNH.

其他以 Philips Medical Systems Nederlands B.V. 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。

K240224澐頓90 K201743ClarifEye R1.0，ClarifEye針 K181311飛利浦血流動力應用 R1.0 K181966智能灌流 K162025IntelliSpace Portal 平台 K153324Ingenia 1.5T 及 Ingenia 1.5T S R5.2

查看所有 7 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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。