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FDA 510(k)

SpotLight CT

K-Number: K161066 · 2016-08-10

ApplicantArineta , Ltd.
Decision Date2016-08-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SpotLight CT is the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2016-08-10 under 510(k) number K161066. 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 CT?

SpotLight CT is a medical device that received FDA 510(k) clearance on 2016-08-10. The listed applicant is Arineta , Ltd.. The 510(k) number is K161066.

When did SpotLight CT receive FDA 510(k) clearance?

SpotLight CT received FDA 510(k) clearance on 2016-08-10, under 510(k) number K161066.

Who is the listed applicant for SpotLight CT?

The FDA 510(k) record lists Arineta , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpotLight CT?

The FDA product code for SpotLight CT is JAK.

Other records listing Arineta , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionK241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionK230370SpotLight/SpotLight Duo (with DLIR option)K213465CardioGraphe

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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