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FDA 510(k)

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

K-Number: K250650 · 2025-04-15

ApplicantArineta , Ltd.
Decision Date2025-04-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a medical device manufactured by Arineta , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under approval number K250650. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is a medical device that received FDA 510(k) clearance on 2025-04-15. It is manufactured by Arineta , Ltd.. The 510(k) number is K250650.

When was SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option approved by the FDA?

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option received FDA 510(k) clearance on 2025-04-15, under approval number K250650.

What company makes SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is manufactured by Arineta , Ltd..

What is the FDA product code for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

The FDA product code for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option is JAK.

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Other Devices by Arineta , Ltd.

K161066SpotLight CT K213465CardioGraphe K230370SpotLight/SpotLight Duo (with DLIR option) K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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