FDA 510(k)

Pinnacle 放射治疗计划系统

K号: K170086 · 2017-02-09

申请人Philips Medical Systems (Cleveland), Inc.

决定日期2017-02-09

产品代码MUJ

咨询委员会RA

决定实质等同

器械摘要

Pinnacle Radiation Therapy Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K170086. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pinnacle Radiation Therapy Planning System?

Pinnacle Radiation Therapy Planning System is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K170086.

When did Pinnacle Radiation Therapy Planning System receive FDA 510(k) clearance?

Pinnacle Radiation Therapy Planning System received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170086.

Who is the listed applicant for Pinnacle Radiation Therapy Planning System?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pinnacle Radiation Therapy Planning System?

The FDA product code for Pinnacle Radiation Therapy Planning System is MUJ.

列明Philips Medical Systems (Cleveland), 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。

K171850Philips CT Big Bore K172406Ingenuity TF K162838Philips iCT CT系统 K163711IQon Spectral CT K160743Philips Ingenuity CT K153444Philips 多层CT系统，配备低剂量CT肺癌

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