DR 800带DSA，DR 800
K号: K212145 · 2021-08-31
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器械摘要
DR 800 with DSA, DR 800 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 2021-08-31 under 510(k) number K212145. 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 DR 800 with DSA, DR 800?
DR 800 with DSA, DR 800 is a medical device that received FDA 510(k) clearance on 2021-08-31. The listed applicant is Agfa N.V.. The 510(k) number is K212145.
When did DR 800 with DSA, DR 800 receive FDA 510(k) clearance?
DR 800 with DSA, DR 800 received FDA 510(k) clearance on 2021-08-31, under 510(k) number K212145.
Who is the listed applicant for DR 800 with DSA, DR 800?
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 DSA, DR 800?
The FDA product code for DR 800 with DSA, DR 800 is JAA.
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。
相关器械（代码：JAA）
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
在 FDA 数据库中查看 →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。
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