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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 the device name listed in this FDA 510(k) record. The listed applicant is Arineta , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) 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. The listed applicant is Arineta , Ltd.. The 510(k) number is K250650.

When did SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option receive FDA 510(k) clearance?

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

Who is the listed applicant for SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option?

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 / 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.

Related Clinical Trials

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.

NCT06825078Performance of Lung MRI Combined to Synthetic CT in the Follow-up of Lung NodulesRECRUITINGNCT06124118Tumor Treating Fields for Locally Advanced NSCLCWITHDRAWNNCT01955018Comparison of the Ultra-low-dose Veo Algorithm With the Gold Standard Filtered Back Projection for Detecting Pulmonary Asbestos-related ConditionsCOMPLETEDNCT07253662Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) in Patients With Peritoneal Metastasis From Pancreatic AdenocarcinomaRECRUITINGNCT07605234Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid MalignanciesNOT_YET_RECRUITINGNCT07631572Cs-131LDR Brachytherapy for Organ-Preserving Irradiation for Recurrent Cervical and Endometrial CancerRECRUITING

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.

K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionK230370SpotLight/SpotLight Duo (with DLIR option)K213465CardioGrapheK161066SpotLight CT

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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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