OnSight 3D Extremity System
K号: K173478 · 2018-01-19
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器械摘要
OnSight 3D Extremity System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173478. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OnSight 3D Extremity System?
OnSight 3D Extremity System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Carestream Health, Inc.. The 510(k) number is K173478.
When did OnSight 3D Extremity System receive FDA 510(k) clearance?
OnSight 3D Extremity System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173478.
Who is the listed applicant for OnSight 3D Extremity System?
The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OnSight 3D Extremity System?
The FDA product code for OnSight 3D Extremity System is JAK.
相关临床试验
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列明Carestream Health, Inc.为申报人的其他记录
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相关器械（代码：JAK）
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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