510(k) K222179
- Device
- Annalise Enterprise CXR Triage Trauma
- Applicant
- Annalise-Ai Pty , Ltd.
- 510(k) number
- K222179
- Product code
- QFM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-28
- Date received
- 2022-07-22
- Regulation
- 892.2080
- Classification name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Minta Chen
- Address
- Level P, 24 Campbell St. Sydney AU 2000 2000
FDA Registration Numbers
- 3014678441
- 3007734888
- 3011205675
- 3021032044
- 3024844299
- 3034205378
- 3027453703
- 3021230777
- 3029915548
- 3023702863
- 2126677
- 3026753394
- 3030491946
- 3017604664
- 3012453401
- 3014938447
- 3018733944
- 3005156333
- 3014665798
- 9616047
- 3017173128
- 3017840913
Source Documents
Other 510(k) Records For Product Code QFM
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|---|---|---|---|
| K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-05-04 |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 2025-12-11 |
| K250831 | Annalise Enterprise | Annalise-Ai | 2025-04-23 |
| K243808 | Rayvolve PTX-PE | AZmed | 2025-03-21 |
| K243548 | BriefCase-Triage | Aidoc Medical , Ltd. | 2024-12-11 |
| K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024-11-15 |
| K240612 | CINA-VCF | Avicenna.Ai | 2024-05-31 |
| K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | 2024-05-23 |
| K232410 | SmartChest | Milvue | 2024-05-10 |
| K231871 | Radify Triage | Envisionit Deepai, Ltd. | 2024-01-17 |
| K223754 | BraveCX | Bering, Ltd. | 2023-11-09 |
| K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023-08-22 |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023-07-27 |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty , Ltd. | 2023-03-28 |
| K223443 | Viz AAA | Viz. Ai, Inc. | 2023-03-17 |