FDA 510(k)

DRX-Evolution 配备 Carestream 数字断层扫描

K号: K191879 · 2019-12-20

决定日期2019-12-20

产品代码KPR

咨询委员会RA

决定实质等同

器械摘要

DRX-Evolution with Carestream Digital Tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K191879. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DRX-Evolution with Carestream Digital Tomosynthesis?

DRX-Evolution with Carestream Digital Tomosynthesis is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Carestream Health, Inc.. The 510(k) number is K191879.

When did DRX-Evolution with Carestream Digital Tomosynthesis receive FDA 510(k) clearance?

DRX-Evolution with Carestream Digital Tomosynthesis received FDA 510(k) clearance on 2019-12-20, under 510(k) number K191879.

Who is the listed applicant for DRX-Evolution with Carestream Digital Tomosynthesis?

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

What is the FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis?

The FDA product code for DRX-Evolution with Carestream Digital Tomosynthesis is KPR.

列明Carestream Health, Inc.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。

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官方来源

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