Revolution Ascend
K号: K213938 · 2022-02-04
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器械摘要
Revolution Ascend is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213938. 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 Revolution Ascend?
Revolution Ascend is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K213938.
When did Revolution Ascend receive FDA 510(k) clearance?
Revolution Ascend received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213938.
Who is the listed applicant for Revolution Ascend?
The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Revolution Ascend?
The FDA product code for Revolution Ascend is JAK.
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。
列明Ge Healthcare Japan Corporation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。
K253686真定义深度学习（True Definition DL）医疗设备监管文本：
本设备符合《医疗器械监督管理条例》的相关规定，已通过美国食品药品监督管理局（FDA）的510(k)审查，并获得PMA批准。临床试验注册号为NCTXXXXXXX，PubMed ID为PMIDXXXXXXX。请访问以下网址获取更多信息：[http://www.example.com]。K233698真增强DL
请注意，由于原文未提供，我无法直接翻译。请提供原文内容，以便我能够准确翻译并遵循您提供的政策。K230807深度学习图像重建K220961深度学习图像重建K212067深度学习图像重建K203169Revolution Ascend
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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