預防AI臨床SDK
K 號：K250233 · 2026-02-13
廣告
器材摘要
PreemptiveAI Clinical SDK is the device name listed in this FDA 510(k) record. The listed applicant is Measure Labs, Inc. (Dba Preemptiveai, Inc.). It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K250233. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the PreemptiveAI Clinical SDK?
PreemptiveAI Clinical SDK is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Measure Labs, Inc. (Dba Preemptiveai, Inc.). The 510(k) number is K250233.
When did PreemptiveAI Clinical SDK receive FDA 510(k) clearance?
PreemptiveAI Clinical SDK received FDA 510(k) clearance on 2026-02-13, under 510(k) number K250233.
Who is the listed applicant for PreemptiveAI Clinical SDK?
The FDA 510(k) record lists Measure Labs, Inc. (Dba Preemptiveai, Inc.) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreemptiveAI Clinical SDK?
The FDA product code for PreemptiveAI Clinical SDK is DXH. This falls under the Hematology category.
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。
相關器械（代碼：DXH）
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。
K250258心輝 Aimigo 配備 12-L 心電圖合成軟體系統Heartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin醫療系統（7100-00016）Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT 心電圖 (QTERD100)QT Medical, Inc.K222842V-Patch 心臟監護器Shandong Corecare Technology Limited
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告