Devices · Gleamer SAS

ChestView US

Gleamer SAS is listed for ChestView US (K241620). The FDA list gives February 27, 2025 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. openFDA describes product code MYN as “Analyzer, Medical Image”: For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers 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=K241620

Official FDA database record

Date of final decision

February 27, 2025

Company on the FDA list

Gleamer SAS

Lead panel

Radiology

Primary product code

MYN

openFDA device name for the code

Analyzer, Medical Image

Device class

2

Regulation number

892.2070

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary