FDA 510(k)

Atellica IM 全部前列腺特异性抗原 II (tPSAII)

K 號：K251630 · 2026-01-05

決定日期2026-01-05

產品代碼LTJ

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

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.

常見問題

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) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

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.