FDA 510(k)

VERITON CT whole body SPECT/CT system

K番号: K182484 · 2018-11-09

決定日2018-11-09

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

VERITON CT whole body SPECT/CT system is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182484. 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 VERITON CT whole body SPECT/CT system?

VERITON CT whole body SPECT/CT system is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K182484.

When did VERITON CT whole body SPECT/CT system receive FDA 510(k) clearance?

VERITON CT whole body SPECT/CT system received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182484.

Who is the listed applicant for VERITON CT whole body SPECT/CT system?

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

What is the FDA product code for VERITON CT whole body SPECT/CT system?

The FDA product code for VERITON CT whole body SPECT/CT system is KPS.

申請者としてSpectrum Dynamics Medical, Ltd.を記載するその他の記録

K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K253532TruSPECT Processing Station K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K212230TruSPECT Radiological Image Processing Station K190457VERITON CT whole body SPECT/CT system K180514VERITON NM

すべての8件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。