ChestView US (1.1)

FDA 510(k) K252486 · Gleamer

Substantially Equivalent

510(k) numberK252486

Submission

Device name
ChestView US (1.1)
Applicant
Gleamer
Paris, FR
Received
August 7, 2025
Decision date
September 9, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYN – Analyzer, Medical Image
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2070
Specialty
Radiology

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

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K251934qXR-DetectMYN · Traditional Qure.Ai Technologies01/16/2026SE
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K252086DTX Studio AssistMYN · Traditional Nobel Biocare C/O Medicim NV11/17/2025SE
K250525Second Opinion® PanoramicMYN · Traditional Pearl, Inc.11/14/2025SE
K250264SugarBug (1.x)MYN · Traditional Bench7, Inc.11/07/2025SE
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More from Videahealth, Inc.

510(k)DeviceDecision
K241620ChestView USMYN · Traditional 02/27/2025SE
K241593BoneMetrics (US)QIH · Traditional 02/05/2025SE
K222176BoneViewQBS · Traditional 03/02/2023SE
K212365BoneViewQBS · Traditional 03/01/2022SE

Questions and answers

When was ChestView US (1.1) cleared by the FDA?

ChestView US (1.1) (K252486) received a 510(k) decision of Substantially Equivalent on September 9, 2026, 398 days after the submission was received.

What is the product code of K252486?

The FDA product code is MYN – Analyzer, Medical Image, a Class II (moderate risk) device regulated under 21 CFR 892.2070.