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FDA 510(k)

Solstice SRS 固定系统；Solstat 固定系统；Solstice 热塑性面具

K号: K182079 · 2018-09-07

申请人Medtec Inc. Dba Civco Medical Solutions
决定日期2018-09-07
产品代码IYE
咨询委员会RA
决定实质等同

器械摘要

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is the device name listed in this FDA 510(k) record. The listed applicant is Medtec Inc. Dba Civco Medical Solutions. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182079. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Medtec Inc. Dba Civco Medical Solutions. The 510(k) number is K182079.

When did Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask receive FDA 510(k) clearance?

Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182079.

Who is the listed applicant for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

The FDA 510(k) record lists Medtec Inc. Dba Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask?

The FDA product code for Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask is IYE.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：IYE）

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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