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FDA 510(k)

Archer PSI 系統

K 號：K243509 · 2025-05-12

申請人3D-Side
決定日期2025-05-12
產品代碼QHE
諮詢委員會或
決定相當於

器材摘要

Archer PSI System is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Side. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K243509. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Archer PSI System?

Archer PSI System is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is 3D-Side. The 510(k) number is K243509.

When did Archer PSI System receive FDA 510(k) clearance?

Archer PSI System received FDA 510(k) clearance on 2025-05-12, under 510(k) number K243509.

Who is the listed applicant for Archer PSI System?

The FDA 510(k) record lists 3D-Side as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Archer PSI System?

The FDA product code for Archer PSI System is QHE.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QHE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260802Materialise Shoulder System™，Materialise Shoulder Guide 及 Model，SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE 系統Orthosoft Inc. (d/b/a) Zimmer CASK251558精準人工智慧外科計劃系統（PAI-SPS）Precision AI Pty, Ltd.K241470核心肩部系統LinkBio Corp.K243955精準人工智慧外科計劃系統（PAI-SPS）Precision AI Pty, Ltd.

官方來源

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