FDA 510(k)

Insight Enhanced DRF Digital Imaging System

K号: K200396 · 2020-03-06

决定日期2020-03-06

产品代码JAA

咨询委员会RA

决定实质等同

器械摘要

Insight Enhanced 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 2020-03-06 under 510(k) number K200396. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Insight Enhanced DRF Digital Imaging System?

Insight Enhanced DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Imaging Engineering, LLC. The 510(k) number is K200396.

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

Insight Enhanced DRF Digital Imaging System received FDA 510(k) clearance on 2020-03-06, under 510(k) number K200396.

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

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

列明Imaging Engineering, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251650Insight Enhanced™ DRF (EN-1002-01)K210469Insight Agile DRF K191310Insight Essentials DRF Digital Imaging System

官方来源

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