FDA 510(k)

CMDR 2ST（複数モデル）、CMDR 2SPE（複数モデル）、Integris

K番号: K171353 · 2017-06-07

決定日2017-06-07

製品コードIZL

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

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171353. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Minxray, Inc.. The 510(k) number is K171353.

When did CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris receive FDA 510(k) clearance?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171353.

Who is the listed applicant for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

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

What is the FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

The FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is IZL.

申請者としてMinxray, Inc.を記載するその他の記録

K210479IMPACTおよびX-Ranger K201575CMDR 2C（複数のモデル）K191451CMDR 2CW（複数のモデル）K182207TR90BH K153059HF1202H パワープラスポータブル X線装置

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