FDA 510(k)

SIGMA P5 / OMEGA P7 / LAMBDA P9 ポータブル超音波診断スキャナー

K番号: K160343 · 2016-04-07

申請者Beijing East Whale Imaging Technology Co., Ltd.

決定日2016-04-07

製品コードIYN

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

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-04-07 under 510(k) number K160343. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is a medical device that received FDA 510(k) clearance on 2016-04-07. The listed applicant is Beijing East Whale Imaging Technology Co., Ltd.. The 510(k) number is K160343.

When did SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner receive FDA 510(k) clearance?

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner received FDA 510(k) clearance on 2016-04-07, under 510(k) number K160343.

Who is the listed applicant for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA 510(k) record lists Beijing East Whale Imaging Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner?

The FDA product code for SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner is IYN.

申請者としてBeijing East Whale Imaging Technology Co., Ltd.を記載するその他の記録

K163429B6 医療機器規制テキストの翻訳は以下の通りです。 B6 （注：URLや識別子など特定の情報は原文のまま維持されています。）K160984マルチスキャンGアームシステム

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