FDA 510(k)

電子足部攝影系統

K 號：K172124 · 2017-11-09

決定日期2017-11-09

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Televere Podiatry Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K172124. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Televere Podiatry Digital Imaging System?

Televere Podiatry Digital Imaging System is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Televere Systems. The 510(k) number is K172124.

When did Televere Podiatry Digital Imaging System receive FDA 510(k) clearance?

Televere Podiatry Digital Imaging System received FDA 510(k) clearance on 2017-11-09, under 510(k) number K172124.

Who is the listed applicant for Televere Podiatry Digital Imaging System?

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

What is the FDA product code for Televere Podiatry Digital Imaging System?

The FDA product code for Televere Podiatry Digital Imaging System is MQB.

其他以 Televere Systems 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170975電子影像系統

相關器械（代碼：MQB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) Limited K250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。