HealthMammo
FDA 510(k) K200905 · Zebra Medical Vision, Ltd.
510(k) numberK200905
Submission
- Device name
- HealthMammo
- Applicant
- Zebra Medical Vision, Ltd.
Sefayim, IL - Received
- April 6, 2020
- Decision date
- July 16, 2020
- 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 |
| 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 |
|---|---|---|
| K211803 | HealthPPTQFM · Traditional | 12/15/2021SE |
| K210085 | HealthCCSngJAK · Traditional | 09/15/2021SE |
| K202487 | HealthJOINTLLZ · Traditional | 12/04/2020SE |
| K192901 | HealthVCFQFM · Traditional | 05/12/2020SE |
| K192320 | HealthCXRQFM · Traditional | 11/26/2019SE |
| K190424 | HealthICHQAS · Traditional | 06/13/2019SE |
| K190362 | HealthPNXQFM · Traditional | 05/06/2019SE |
| K172983 | HealthCCSJAK · Traditional | 06/13/2018SE |
Questions and answers
When was HealthMammo cleared by the FDA?
HealthMammo (K200905) received a 510(k) decision of Substantially Equivalent on July 16, 2020, 101 days after the submission was received.
What is the product code of K200905?
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.