# Nucleushealth, LLC

- Location (FDA's records): San Diego, CA
- FDA decisions: 2 (2017–2020): 2 510(k) clearances
- Product codes: LLZ (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Statrad, LLC: 1 (https://510kreport.com/company/statrad)
- Visage Imaging GmbH: 1 (https://510kreport.com/company/visage-imaging)

## Firms that cite its devices most
- Ramsoft, Inc.: 1 (https://510kreport.com/company/ramsoft)
- Change Healthcare Canada Company: 1 (https://510kreport.com/company/change-healthcare-canada)

## Its most-cited devices
- K203249: Nucleus.io (2020), cited by 2

## Recent decisions
- K203249: Nucleus.io (Dec 4, 2020)
- K171130: Nucleus Image Management System (May 4, 2017)

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