FDA 510(k)

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]。

K号: K253686 · 2026-03-23

决定日期2026-03-23

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

True Definition 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 2026-03-23 under 510(k) number K253686. 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 Definition DL?

True Definition DL is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K253686.

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

True Definition DL received FDA 510(k) clearance on 2026-03-23, under 510(k) number K253686.

Who is the listed applicant for True Definition 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 Definition DL?

The FDA product code for True Definition 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。

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 K213938Revolution Ascend K212067深度学习图像重建 K203169Revolution Ascend

查看所有 8 个设备 →

官方来源

在 FDA 数据库中查看 →

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。

器械摘要

常见问题

相关临床试验

列明Ge Healthcare Japan Corporation为申报人的其他记录

相关器械（代码：JAK）

官方来源