PowerDR
K号: K191504 · 2019-08-16
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器械摘要
PowerDR is the device name listed in this FDA 510(k) record. The listed applicant is Radiology Information Systems, Inc.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191504. 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 PowerDR?
PowerDR is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Radiology Information Systems, Inc.. The 510(k) number is K191504.
When did PowerDR receive FDA 510(k) clearance?
PowerDR received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191504.
Who is the listed applicant for PowerDR?
The FDA 510(k) record lists Radiology Information Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PowerDR?
The FDA product code for PowerDR is JAA.
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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
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