FDA 510(k)

Imbio セグメント編集ツールソフトウェア

K番号: K180129 · 2018-03-16

決定日2018-03-16

製品コードLLZ

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

Imbio Segmentation Editing Tool software is the device name listed in this FDA 510(k) record. The listed applicant is Imbio, LLC. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K180129. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Imbio Segmentation Editing Tool software?

Imbio Segmentation Editing Tool software is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Imbio, LLC. The 510(k) number is K180129.

When did Imbio Segmentation Editing Tool software receive FDA 510(k) clearance?

Imbio Segmentation Editing Tool software received FDA 510(k) clearance on 2018-03-16, under 510(k) number K180129.

Who is the listed applicant for Imbio Segmentation Editing Tool software?

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

What is the FDA product code for Imbio Segmentation Editing Tool software?

The FDA product code for Imbio Segmentation Editing Tool software is LLZ.

申請者としてImbio, LLCを記載するその他の記録

K203256Imbio RV/LV ソフトウェア

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