FDA 510(k)

ネクサスDRTMデジタルX線画像システム（PaxScan 4336Wv4付き）

K番号: K161459 · 2016-09-06

申請者Varian Medical Systems, X-Ray Products-Infimed

決定日2016-09-06

製品コードMQB

諮問委員会RA

決定Substantially Equivalent

医療機器の概要

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161459. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Varian Medical Systems, X-Ray Products-Infimed. The 510(k) number is K161459.

When did Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) receive FDA 510(k) clearance?

Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161459.

Who is the listed applicant for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA 510(k) record lists Varian Medical Systems, X-Ray Products-Infimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)?

The FDA product code for Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) is MQB.

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ネクサスDRTMデジタルX線画像システム（PaxScan 4336Wv4付き）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MQB）

公式ソース