FDA 510(k)

プロテウスXR/f、モデルSTおよびET、マルチラッドおよびマルチラッドNETレントゲンシステム

K番号: K203537 · 2021-02-01

決定日2021-02-01

製品コードKPR

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sedecal., Sa.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) number K203537. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is a medical device that received FDA 510(k) clearance on 2021-02-01. The listed applicant is Sedecal., Sa.. The 510(k) number is K203537.

When did Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems receive FDA 510(k) clearance?

Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203537.

Who is the listed applicant for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

The FDA 510(k) record lists Sedecal., Sa. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems?

The FDA product code for Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems is KPR.

申請者としてSedecal., Sa.を記載するその他の記録

K232185SM-IV K222951SM-V 医療機器規制文の翻訳は以下の通りです。 SM-V K221803フェニックス/AeroDR TX m01およびフェニックス/mKDR Xpress。K212291フェニックス K202293画像診断システム・チャレンジX K192936ソルタス500

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