Annalise Enterprise
FDA 510(k) K250831 · Annalise-Ai
510(k) numberK250831
Submission
- Device name
- Annalise Enterprise
- Applicant
- Annalise-Ai
Sydney, AU - Received
- March 19, 2025
- Decision date
- April 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Envisionit Deepai, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231767 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 09/22/2023SE |
| K231384 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 09/22/2023SE |
| K231094 | Annalise Enterprise CTB Triage-OHQAS · Traditional | 08/15/2023SE |
| K223240 | Annalise Enterprise CTB Triage TraumaQAS · Traditional | 04/03/2023SE |
| K222268 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | 03/28/2023SE |
| K222179 | Annalise Enterprise CXR Triage TraumaQFM · Traditional | 03/28/2023SE |
| K213941 | Annalise Enterprise CXR Triage PneumothoraxQFM · Traditional | 02/24/2022SE |
Questions and answers
When was Annalise Enterprise cleared by the FDA?
Annalise Enterprise (K250831) received a 510(k) decision of Substantially Equivalent on April 23, 2025, 35 days after the submission was received.
What is the product code of K250831?
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.