VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
FDA 510(k) K241439 · Vuno, Inc.
Submission
- Device name
- VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
- Applicant
- Vuno, Inc.
Seoul, KR - Received
- May 21, 2024
- Decision date
- November 15, 2024
- 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…
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|---|---|---|---|
| K253751 | CXRDetectAIQFM · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/08/2026SE |
| 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 |
| 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 |
More from Envisionit Deepai, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231398 | VUNO Med-DeepBrainQIH · Traditional | 10/04/2023SE |
Questions and answers
When was VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage cleared by the FDA?
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (K241439) received a 510(k) decision of Substantially Equivalent on November 15, 2024, 178 days after the submission was received.
What is the product code of K241439?
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.