FDA 510(k)

Atellica IM 总PSA II (tPSAII)

K号: K251630 · 2026-01-05

决定日期2026-01-05

产品代码LTJ

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决定实质等同

器械摘要

Atellica IM Total PSA II (tPSAII) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) number K251630. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Atellica IM Total PSA II (tPSAII)?

Atellica IM Total PSA II (tPSAII) is a medical device that received FDA 510(k) clearance on 2026-01-05. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K251630.

When did Atellica IM Total PSA II (tPSAII) receive FDA 510(k) clearance?

Atellica IM Total PSA II (tPSAII) received FDA 510(k) clearance on 2026-01-05, under 510(k) number K251630.

Who is the listed applicant for Atellica IM Total PSA II (tPSAII)?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Atellica IM Total PSA II (tPSAII)?

The FDA product code for Atellica IM Total PSA II (tPSAII) is LTJ.

列明Siemens Healthcare Diagnostics, Inc.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。

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