FDA 510(k)

SpotLight/SpotLight Duo で低線量肺がんスクリーニングオプション付き

K番号: K241200 · 2025-01-13

決定日2025-01-13

製品コードJAK

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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 2025-01-13 under 510(k) number K241200. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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 2025-01-13. The listed applicant is Arineta , Ltd.. The 510(k) number is K241200.

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 2025-01-13, under 510(k) number K241200.

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.

申請者としてArineta , Ltd.を記載するその他の記録

K250650スポットライト / スポットライト・デュオ低位線量肺がんスクリーニングオプション K230370SpotLight/SpotLight Duo（DLIRオプション付き）K213465カーディオグラフ K161066スポットライトCT

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