SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200)
Description
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option by Arineta , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241200
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screeni... | Arineta , Ltd. | 2025 |
Trace the full predicate network for K241200
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.