BriefCase
FDA 510(k) K214043 · Aidoc Medical , Ltd.
510(k) numberK214043
Submission
- Device name
- BriefCase
- Applicant
- Aidoc Medical , Ltd.
Tell-Aviv, IL - Received
- December 23, 2021
- Decision date
- March 14, 2022
- 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 |
|---|---|---|---|
| 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 |
| 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 |
More from Milvue
| 510(k) | Device | Decision |
|---|---|---|
| K261317 | BriefCase-TriageQAS · Special | 05/14/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | 01/07/2026SE |
| K253265 | BriefCase-TriageQAS · Special | 11/06/2025SE |
| K251406 | BriefCase-TriageQAS · Special | 05/30/2025SE |
| K250248 | BriefCase-TriageQAS · Special | 02/14/2025SE |
| K243548 | BriefCase-TriageQFM · Special | 12/11/2024SE |
| K242203 | BriefCase-QuantificationQIH · Traditional | 11/22/2024SE |
| K242837 | BriefCase-TriageQAS · Special | 10/18/2024SE |
Questions and answers
When was BriefCase cleared by the FDA?
BriefCase (K214043) received a 510(k) decision of Substantially Equivalent on March 14, 2022, 81 days after the submission was received.
What is the product code of K214043?
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.