FDA 510(k)

Insight Essentials DRF數位影像系統

K 號：K191310 · 2019-06-10

決定日期2019-06-10

產品代碼JAA

諮詢委員會RA

決定相當於

器材摘要

Insight Essentials DRF Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Engineering, LLC. It received FDA 510(k) clearance on 2019-06-10 under 510(k) number K191310. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Insight Essentials DRF Digital Imaging System?

Insight Essentials DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K191310.

When did Insight Essentials DRF Digital Imaging System receive FDA 510(k) clearance?

Insight Essentials DRF Digital Imaging System received FDA 510(k) clearance on 2019-06-10, under 510(k) number K191310.

Who is the listed applicant for Insight Essentials DRF Digital Imaging System?

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

What is the FDA product code for Insight Essentials DRF Digital Imaging System?

The FDA product code for Insight Essentials DRF Digital Imaging System is JAA.

其他以 Imaging Engineering, 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。

K251650Insight Enhanced™ DRF (EN-1002-01)K210469洞察敏捷DRF K200396洞察強化DRF數位影像系統

相關器械（代碼：JAA）

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。

K253103Nexus DRF數位X光影像系統Varex Imaging Corporation K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT 電子顯微鏡系統Dornier Medtech America K233945ProxiDiagnost N90 / 精準CRF (706110, 706400)Philips Medical Systems Dmc GmbH

官方來源

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