FDA 510(k)

DR 800 配备断层扫描

K号: K183275 · 2019-02-01

决定日期2019-02-01

产品代码IZF

咨询委员会RA

决定实质等同

器械摘要

DR 800 with Tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K183275. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DR 800 with Tomosynthesis?

DR 800 with Tomosynthesis is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Agfa N.V.. The 510(k) number is K183275.

When did DR 800 with Tomosynthesis receive FDA 510(k) clearance?

DR 800 with Tomosynthesis received FDA 510(k) clearance on 2019-02-01, under 510(k) number K183275.

Who is the listed applicant for DR 800 with Tomosynthesis?

The FDA 510(k) record lists Agfa N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR 800 with Tomosynthesis?

The FDA product code for DR 800 with Tomosynthesis is IZF.

列明Agfa N.V.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。

K213469VALORY K212145DR 800带DSA，DR 800 K211790DX-D Imaging Package with XD Detectors K193262DR 600带断层扫描 K191884DR 100s

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。