# Vysioneer, Inc.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 3 (2021–2021): 3 510(k) clearances
- Product codes: QKB (3)
- 510(k) review time since 2016: median 97 days, against 120 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xiamen Manteia Technology, Ltd.: 2 (https://510kreport.com/company/xiamen-manteia-technology)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)

## Firms that cite its devices most
- Neosoma, Inc.: 1 (https://510kreport.com/company/neosoma)
- Taiwan Medical Imaging Co., Ltd.: 1 (https://510kreport.com/company/taiwan-medical-imaging)
- Aitewan Biomedical Technology, Inc.: 1 (https://510kreport.com/company/aitewan-biomedical-technology)

## Its most-cited devices
- K203235: VBrain (2021), cited by 4
- K212116: VBrain-OAR (2021), cited by 1

## Recent decisions
- K213628: VBrain (Dec 16, 2021)
- K212116: VBrain-OAR (Oct 12, 2021)
- K203235: VBrain (Mar 19, 2021)

Source page: https://510kreport.com/company/vysioneer