FDA 510(k)

HeartSee 心脏 P.E.T. 处理软件

K号: K181343 · 2018-06-12

决定日期2018-06-12

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

HeartSee Cardiac P.E.T. Processing Software is the device name listed in this FDA 510(k) record. The listed applicant is Bracco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-12 under 510(k) number K181343. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HeartSee Cardiac P.E.T. Processing Software?

HeartSee Cardiac P.E.T. Processing Software is a medical device that received FDA 510(k) clearance on 2018-06-12. The listed applicant is Bracco Diagnostics, Inc.. The 510(k) number is K181343.

When did HeartSee Cardiac P.E.T. Processing Software receive FDA 510(k) clearance?

HeartSee Cardiac P.E.T. Processing Software received FDA 510(k) clearance on 2018-06-12, under 510(k) number K181343.

Who is the listed applicant for HeartSee Cardiac P.E.T. Processing Software?

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

What is the FDA product code for HeartSee Cardiac P.E.T. Processing Software?

The FDA product code for HeartSee Cardiac P.E.T. Processing Software is KPS.

列明Bracco Diagnostics, 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。

K243881HeartSee™ 心脏 P.E.T. 处理软件用于心肌灌注和冠状动脉血流储备 (CFR) 版本 4

相关器械（代码：KPS）

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。

官方来源

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