CXRDetectAI— 510(k) K253751
Substantially EquivalentNeurocareai, 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.
Summary
CXRDetectAI from Neurocareai (doing business as Savelife.Ai) is filed under QFM, radiological computer-assisted prioritization software for lesions. The record doesn't describe the software's inputs or outputs.
Class II, 21 CFR 892.2080. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Neurocareai filed from Prosper, Texas. Review took 225 calendar days (November 25, 2025 to July 8, 2026).
Clearance details
- Applicant
- Neurocareai, Inc. (Dba Savelife.Ai)
- Product code
- Product code QFM
- Device class
- Class 2
- Regulation
- 21 CFR 892.2080
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prosper, TX, US
Recent devices under product code QFM
view allMore clearances from Neurocareai, Inc. (Dba Savelife.Ai)
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