# Candelis, Inc.

- Location (FDA's records): Denton, TX
- FDA decisions: 4 (2008–2026): 4 510(k) clearances
- Product codes: LLZ (4)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 6 (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
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)

## Firms that cite its devices most
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.: 1 (https://510kreport.com/company/compania-mexicana-de-radiologia-cgr)
- Ultralinq Healthcare Solutions, Inc.: 1 (https://510kreport.com/company/ultralinq-healthcare-solutions)
- Intuitive Imaging Informatics, LLC: 1 (https://510kreport.com/company/intuitive-imaging-informatics)

## Its most-cited devices
- K092949: Imagegrid Radiology Viewer System (2009), cited by 3
- K111694: ASTRA (2011), cited by 2
- K080333: Imagegrid (2008), cited by 1

## Recent decisions
- K262143: ImageGrid StreamVue (Jul 23, 2026)
- K111694: ASTRA (Sep 15, 2011)
- K092949: Imagegrid Radiology Viewer System (Oct 8, 2009)
- K080333: Imagegrid (Feb 22, 2008)

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