SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
FDA 510(k) K241200 · Arineta , Ltd.
510(k) numberK241200
Submission
- Device name
- SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
- Applicant
- Arineta , Ltd.
Caesarea, IL - Received
- April 30, 2024
- Decision date
- January 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
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| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionJAK · Traditional | 04/15/2025SE |
| K230370 | SpotLight/SpotLight Duo (with DLIR option)JAK · Traditional | 10/13/2023SE |
| K213465 | CardioGrapheJAK · Traditional | 12/02/2022SE |
| K161066 | SpotLight CTJAK · Traditional | 08/10/2016SE |
Questions and answers
When was SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option cleared by the FDA?
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200) received a 510(k) decision of Substantially Equivalent on January 13, 2025, 258 days after the submission was received.
What is the product code of K241200?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.