CXRDetectAI— 510(k) K253751

Name: FDA 510(k) clearance K253751
Creator: U.S. Food and Drug Administration
Published: 2026-07-08

Substantially Equivalent

Neurocareai, Inc. (Dba Savelife.Ai)

FDA 510(k) clearance K253751 for CXRDetectAI, Substantially Equivalent on 2026-07-08. Applicant: Neurocareai, Inc. (Dba Savelife.Ai). Device class: 2.

Clearance details

Applicant: Neurocareai, Inc. (Dba Savelife.Ai)
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-11-25
Decision date: 2026-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prosper, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.