FDA 510(k)

先制AI臨床SDK

K番号: K250233 · 2026-02-13

申請者Measure Labs, Inc. (Dba Preemptiveai, Inc.)

決定日2026-02-13

製品コードDXH

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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先制AI臨床SDK

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：DXH）

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