FDA 510(k)

SPY 便携式手持成像（SPY-PHI）系统

K号: K190729 · 2019-04-19

申请人Novadaq Technologies Ulc. (Now A Part of Stryker)

决定日期2019-04-19

产品代码OWN

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

SPY Portable Handheld Imaging (SPY-PHI) System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K190729. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常见问题

What is the SPY Portable Handheld Imaging (SPY-PHI) System?

SPY Portable Handheld Imaging (SPY-PHI) System is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K190729.

When did SPY Portable Handheld Imaging (SPY-PHI) System receive FDA 510(k) clearance?

SPY Portable Handheld Imaging (SPY-PHI) System received FDA 510(k) clearance on 2019-04-19, under 510(k) number K190729.

Who is the listed applicant for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA 510(k) record lists Novadaq Technologies Ulc. (Now A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System?

The FDA product code for SPY Portable Handheld Imaging (SPY-PHI) System is OWN.

列明Novadaq Technologies Ulc. (Now A Part of Stryker)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。

K202244配备 SPY-PHI 荧光评估软件的 SPY-PHI 系统 K200737SPY 便携式手持成像（SPY-PHI）系统 K192174SPY 便携式手持成像（SPY-PHI）系统 K182907SPY Elite 手术室灌注评估系统 K182606PINPOINT 内窥镜荧光成像系统

官方来源

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