FDA 510(k)

D-SPECT処理およびレビューワークステーション

K番号: K160120 · 2016-03-21

決定日2016-03-21

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

D-SPECT Processing and Reviewing Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K160120. 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 D-SPECT Processing and Reviewing Workstation?

D-SPECT Processing and Reviewing Workstation is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Spectrum Dynamics , Ltd.. The 510(k) number is K160120.

When did D-SPECT Processing and Reviewing Workstation receive FDA 510(k) clearance?

D-SPECT Processing and Reviewing Workstation received FDA 510(k) clearance on 2016-03-21, under 510(k) number K160120.

Who is the listed applicant for D-SPECT Processing and Reviewing Workstation?

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

What is the FDA product code for D-SPECT Processing and Reviewing Workstation?

The FDA product code for D-SPECT Processing and Reviewing Workstation is KPS.

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D-SPECT処理およびレビューワークステーション

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KPS）

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