# Arineta, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 5 (2016–2025): 5 510(k) clearances
- Product codes: JAK (5)
- 510(k) review time since 2016: median 245 days, against 139 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 4 (4 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
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)

## Its most-cited devices
- K213465: CardioGraphe (2022), cited by 1
- K241200: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (2025), cited by 1
- K161066: SpotLight CT (2016), cited by 1
- K230370: SpotLight/SpotLight Duo (with DLIR option) (2023), cited by 1

## Recent decisions
- K250650: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (Apr 15, 2025)
- K241200: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (Jan 13, 2025)
- K230370: SpotLight/SpotLight Duo (with DLIR option) (Oct 13, 2023)
- K213465: CardioGraphe (Dec 2, 2022)
- K161066: SpotLight CT (Aug 10, 2016)

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