CXRDetectAI
FDA 510(k) K253751 · Neurocareai, Inc. (Dba Savelife.Ai)
Submission
- Device name
- CXRDetectAI
- Applicant
- Neurocareai, Inc. (Dba Savelife.Ai)
Prosper, TX, US - Received
- November 25, 2025
- Decision date
- July 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFM – Radiological Computer-Assisted Prioritization Software For Lesions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
Other 510(k)s with product code QFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252954 | MammoSightAIQFM · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 05/04/2026SE |
| K252482 | CogNet AI-MT+QFM · Traditional | Medcognetics, Inc. | 12/11/2025SE |
| K250831 | Annalise EnterpriseQFM · Special | Annalise-Ai | 04/23/2025SE |
| K243808 | Rayvolve PTX-PEQFM · Traditional | AZmed | 03/21/2025SE |
| K243548 | BriefCase-TriageQFM · Special | Aidoc Medical , Ltd. | 12/11/2024SE |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageQFM · Traditional | Vuno, Inc. | 11/15/2024SE |
| K240612 | Cina-VcfQFM · Traditional | Avicenna.Ai | 05/31/2024SE |
| K233108 | VinDr-MammoQFM · Traditional | Vinbigdata Joint Stock Company | 05/23/2024SE |
| K232410 | SmartChestQFM · Traditional | Milvue | 05/10/2024SE |
| K231871 | Radify TriageQFM · Abbreviated | Envisionit Deepai, Ltd. | 01/17/2024SE |
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Questions and answers
When was CXRDetectAI cleared by the FDA?
CXRDetectAI (K253751) received a 510(k) decision of Substantially Equivalent on July 8, 2026, 225 days after the submission was received.
What is the product code of K253751?
The FDA product code is QFM – Radiological Computer-Assisted Prioritization Software For Lesions, a Class II (moderate risk) device regulated under 21 CFR 892.2080.