FDA 510(k)

心臓見 Cardiac P.E.T. プロセッシングソフトウェア用オプションスクリーンディスプレイ - HeartSee バージョン 3

K番号: K202679 · 2021-04-12

決定日2021-04-12

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

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2021-04-12 under 510(k) number K202679. 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 Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is a medical device that received FDA 510(k) clearance on 2021-04-12. The listed applicant is Mcgovern Medical School. The 510(k) number is K202679.

When did Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 receive FDA 510(k) clearance?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 received FDA 510(k) clearance on 2021-04-12, under 510(k) number K202679.

Who is the listed applicant for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

The FDA 510(k) record lists Mcgovern Medical School as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

The FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is KPS.

申請者としてMcgovern Medical Schoolを記載するその他の記録

K231731オプションのHeartSee Cardiac P.E.T.処理ソフトウェアのスクリーンディスプレイ - HeartSeeバージョン4

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。