FDA 510(k)

イメージSPECT

K番号: K152503 · 2016-01-25

決定日2016-01-25

製品コードKPS

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

ImagenSPECT is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K152503. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ImagenSPECT?

ImagenSPECT is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Cardiovascular Imaging Technologies. The 510(k) number is K152503.

When did ImagenSPECT receive FDA 510(k) clearance?

ImagenSPECT received FDA 510(k) clearance on 2016-01-25, under 510(k) number K152503.

Who is the listed applicant for ImagenSPECT?

The FDA 510(k) record lists Cardiovascular Imaging Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ImagenSPECT?

The FDA product code for ImagenSPECT is KPS.

申請者としてCardiovascular Imaging Technologiesを記載するその他の記録

K201933イメージSPECT 3.0 K173547イメージユニバーサル

関連機器（コード：KPS）

公式ソース

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