Devices · Arineta Ltd.

SpotLight/SpotLight Duo (with DLIR option)

Arineta Ltd. is listed for SpotLight/SpotLight Duo (with DLIR option) (K230370). The FDA list gives October 13, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JAK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230370

Official FDA database record

Date of final decision

October 13, 2023

Company on the FDA list

Arineta Ltd.

Lead panel

Radiology

Primary product code

JAK

openFDA device name for the code

System, X-Ray, Tomography, Computed

Device class

2

Regulation number

892.1750

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary