Arineta , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionApril 15, 2025
K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionJanuary 13, 2025
K230370SpotLight/SpotLight Duo (with DLIR option)October 13, 2023
K213465CardioGrapheDecember 2, 2022
K161066SpotLight CTAugust 10, 2016