FDA 510(k)

系統、施用器、放射性同位素、遙控

K 號：K170203 · 2017-06-01

決定日期2017-06-01

產品代碼JAQ

諮詢委員會RA

決定相當於

器材摘要

System, Applicator, Radionuclide, Remote Controlled is the device name listed in this FDA 510(k) record. The listed applicant is Kobold, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170203. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the System, Applicator, Radionuclide, Remote Controlled?

System, Applicator, Radionuclide, Remote Controlled is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Kobold, LLC. The 510(k) number is K170203.

When did System, Applicator, Radionuclide, Remote Controlled receive FDA 510(k) clearance?

System, Applicator, Radionuclide, Remote Controlled received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170203.

Who is the listed applicant for System, Applicator, Radionuclide, Remote Controlled?

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

What is the FDA product code for System, Applicator, Radionuclide, Remote Controlled?

The FDA product code for System, Applicator, Radionuclide, Remote Controlled is JAQ.

其他以 Kobold, LLC 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。

K160610Kobold Fletcher型雙連環及卵形施用器組，Kobold Henschke型雙連環及卵形施用器組，Kobold陰道柱狀施用器組，Kobold Miami柱狀施用器組

相關器械（代碼：JAQ）

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。

K262383LumenCare 銀河Nucletron B.V.K252717MAASTRO 直腸施藥器組Varian Medical Systems K251037直腸施藥器Nucletron B.V.K252884導向阿魯斯應用器組Varian Medical Systems K250299CT/ MR 串聯及卵形組合Varian Medical Systems, Inc.K250289內腔/間質系統Varian Medical Systems

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。