# K233108: VinDr-Mammo

- Pathway: 510(k) (Traditional)
- Applicant: Vinbigdata Joint Stock Company
- Decided: May 23, 2024 after 239 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220080: CogNet QmTRIAGE, Medcognetics, Inc. (2022) Summary page 5.

## Indications for use
The VinDr-Mammo is a passive notification for prioritization-only, a parallel-workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. VinDr-Mammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam-level. VinDr-Mammo produces an exam-level output to a PACS/Workstation for flagging the suspicious case and allows worklist prioritization. MQSA qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography, according to the current standard of care. VinDr-Mammo device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician's worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The VinDr-Mammo device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems only.

Source page: https://510kreport.com/device/K233108
Methodology: https://510kreport.com/methodology