MYN

Analyzer, Medical Image

Product code
MYN
Device name
Analyzer, Medical Image
Device class
Class 2
21 CFR
21 CFR 892.2070
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
29
Summaries archived here
25 (direct download)
510(k) clearances (all years, FDA)
39 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (29)

Last three years. Most recent: 2026-08-06.

NumberDecision dateApplicantDevice nameSummary
K2610592026-08-06Overjet, Inc.Overjet Multi-Image Caries and Charting AssistFDA
K2608512026-07-15Better Diagnostics AI Corp.Better Diagnostics Dental Assist (BDDA) Version 1.0PDF
K2529532026-05-11Velmeni, Inc.Velmeni for Dentists (V4D) Endo-PerioFDA
K2519342026-01-16Qure.Ai TechnologiesqXR-DetectPDF
K2529342026-01-15DGNCT, LLCDiagnocatPDF
K2530092026-01-07Dentsply Sirona, Inc.DS Core DetectPDF
K2520862025-11-17Nobel Biocare C/O Medicim NVDTX Studio AssistPDF
K2505252025-11-14Pearl, Inc.Second Opinion® PanoramicPDF
K2502642025-11-07Bench7, Inc.SugarBug (1.x)PDF
K2510022025-09-19Videahealth, Inc.Videa Dental AIPDF
K2507532025-09-02Velmeni, Inc.VELMENI for DENTISTS (V4D)PDF
K2432342025-06-12Pearl, Inc.Second Opinion® CSPDF
K2424372025-05-14Cube Click, Inc.Smile Dx®PDF
K2438932025-05-05Pearl, Inc.Second Opinion® PediatricFDA
K2432392025-04-24Exo, Inc.Lung AI (LAI001)PDF
K2426002025-04-11Pearl, Inc.Second Opinion Periapical Radiolucency ContoursPDF
K2438312025-03-26AZmedRayvolve LNPDF
K2417252025-03-11Better Diagnostics AI Corp.Better Diagnostics Caries Assist (BDCA) Version 1.0PDF
K2416202025-02-27Gleamer SasChestView USPDF
K2425222025-01-16Pearl, Inc.Second Opinion CCFDA
K2400032024-08-30Velmeni, Inc.Velmeni for Dentists (V4D)PDF
K2337382024-03-04Overjet, Inc.Overjet Caries Assist-PediatricPDF
K2318052023-12-22Qure.Ai TechnologiesqXR-LNPDF
K2323842023-12-15Videahealth, Inc.Videa Dental AssistPDF
K2301442023-10-06Denti.Ai Technology, Inc.Denti.AI DetectPDF
K2310012023-10-05Deeptek Medical Imaging Pvt, Ltd.DeepTek CXR Analyzer v1.0PDF
K2300852023-10-03Imagen Technologies, Inc.Lung-CADPDF
K2316782023-09-21Overjet, Inc.Overjet Periapical Radiolucency AssistPDF
K2238112023-09-13Imagen Technologies, Inc.Lung-CADPDF

25 summaries are archived here for direct download.

Official FDA classification page: MYN
Classification and pathway per current FDA publications. Data from openFDA (CC0).