FDA 510(k)

ANYVIEW-500R 腔影手術機動 X 射線系統

K 號：K160279 · 2016-10-14

決定日期2016-10-14

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

ANYVIEW-500R Fluoroscopic Mobile X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Ecotron Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K160279. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

ANYVIEW-500R Fluoroscopic Mobile X-Ray System is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Ecotron Co., Ltd.. The 510(k) number is K160279.

When did ANYVIEW-500R Fluoroscopic Mobile X-Ray System receive FDA 510(k) clearance?

ANYVIEW-500R Fluoroscopic Mobile X-Ray System received FDA 510(k) clearance on 2016-10-14, under 510(k) number K160279.

Who is the listed applicant for ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

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

What is the FDA product code for ANYVIEW-500R Fluoroscopic Mobile X-Ray System?

The FDA product code for ANYVIEW-500R Fluoroscopic Mobile X-Ray System is OWB.

其他以 Ecotron Co., Ltd. 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。

K221233DT-703 K180473ANYVIEW DR 系列 FPD 腔影手術機臂 ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

相關器械（代碼：OWB）

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。

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官方來源

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