FDA 510(k)

PreemptiveAI 临床 SDK

K号: K250233 · 2026-02-13

申请人Measure Labs, Inc. (Dba Preemptiveai, Inc.)

决定日期2026-02-13

产品代码DXH

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

PreemptiveAI 临床 SDK

器械摘要

常见问题

相关临床试验

相关器械（代码：DXH）

官方来源