Cleared Traditional

K241620 - ChestView US

K241620 is an FDA 510(k) clearance for ChestView US, manufactured by Gleamer Sas. The device is a Class 2 Radiology device with product code MYN cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K241620 · Gleamer Sas · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
267d
Days
Class 2
Risk

K241620 is an FDA 510(k) clearance for the ChestView US. Classified as Analyzer, Medical Image (product code MYN), Class II - Special Controls.

Submitted by Gleamer Sas (Paris, FR). The FDA issued a Cleared decision on February 27, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2070 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gleamer Sas devices

FDA 510(k) Submission Details - K241620

510(k) Number K241620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2024
Decision Date February 27, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYN Device Classification - Class 2, Special Controls

Product Code MYN Analyzer, Medical Image
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2070
Definition 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MYN Analyzer, Medical Image

All 36
Devices cleared under the same product code (MYN) and FDA review panel - the closest regulatory comparables to K241620.
Second Opinion Periapical Radiolucency Contours
K242600 · Pearl, Inc. · Apr 2025
Rayvolve LN
K243831 · AZmed · Mar 2025
Better Diagnostics Caries Assist (BDCA) Version 1.0
K241725 · Better Diagnostics AI Corp. · Mar 2025
Second Opinion CC
K242522 · Pearl, Inc. · Jan 2025
Velmeni for Dentists (V4D)
K240003 · Velmeni, Inc. · Aug 2024
Overjet Caries Assist-Pediatric
K233738 · Overjet, Inc. · Mar 2024