FDA 510(k)

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K号: K233698 · 2024-04-11

决定日期2024-04-11

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

True Enhance DL 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 2024-04-11 under 510(k) number K233698. 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 True Enhance DL?

True Enhance DL is a medical device that received FDA 510(k) clearance on 2024-04-11. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K233698.

When did True Enhance DL receive FDA 510(k) clearance?

True Enhance DL received FDA 510(k) clearance on 2024-04-11, under 510(k) number K233698.

Who is the listed applicant for True Enhance DL?

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 True Enhance DL?

The FDA product code for True Enhance DL is JAK.

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]。K230807深度学习图像重建 K220961深度学习图像重建 K213938Revolution Ascend K212067深度学习图像重建 K203169Revolution Ascend

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。