Product code

AI devices with FDA product code MYN — Analyzer, Medical Image

Product code MYN (“Analyzer, Medical Image” in openFDA) covers 43 devices on the FDA AI-enabled list, from 33 companies. Most are reviewed by the Radiology panel (43). The most recent decision was Velmeni for Dentists (V4D) Endo-Perio on May 11, 2026.

43AI devices

25Companies

1998First decision

2026-05-11Latest decision

Trend: devices per year

19982001200220162017202120222023202420252026

AI devices with FDA product code MYN — Analyzer, Medical Image per year: 1998 2, 2001 1, 2002 1, 2016 1, 2017 1, 2021 2, 2022 5, 2023 10, 2024 2, 2025 14, 2026 4

Top companies

Pearl Inc.4
Imagen Technologies, Inc4
Pearl, Inc.2
Velmeni Inc.2
Overjet, Inc2
Overjet, Inc.2
Velmeni, Inc.1
Qure.Ai Technologies1
DGNCT, LLC1
Dentsply Sirona, Inc.1

All 43 devices, newest first

Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc. · RadiologyK2529532026-05-11
qXR-DetectQure.Ai Technologies · RadiologyK2519342026-01-16
DiagnocatDGNCT, LLC · RadiologyK2529342026-01-15
DS Core DetectDentsply Sirona, Inc. · RadiologyK2530092026-01-07
DTX Studio AssistNobel Biocare C/O Medicim NV · RadiologyK2520862025-11-17
Second Opinion® PanoramicPearl, Inc. · RadiologyK2505252025-11-14
SugarBug (1.x)Bench7, Inc. · RadiologyK2502642025-11-07
Videa Dental AIVideaHealth Inc. · RadiologyK2510022025-09-19
VELMENI for DENTISTS (V4D)Velmeni Inc. · RadiologyK2507532025-09-02
Second Opinion® CSPearl Inc. · RadiologyK2432342025-06-12
Smile Dx®Cube Click, Inc. · RadiologyK2424372025-05-14
Second Opinion® PediatricPearl, Inc. · RadiologyK2438932025-05-05
Lung AI (LAI001)Exo Inc · RadiologyK2432392025-04-24
Second Opinion Periapical Radiolucency ContoursPearl Inc. · RadiologyK2426002025-04-11
Rayvolve LNAZmed · RadiologyK2438312025-03-26
Better Diagnostics Caries Assist (BDCA) Version 1.0Better Diagnostics AI Corp · RadiologyK2417252025-03-11
ChestView USGleamer SAS · RadiologyK2416202025-02-27
Second Opinion CCPearl Inc. · RadiologyK2425222025-01-16
Velmeni for Dentists (V4D)Velmeni Inc. · RadiologyK2400032024-08-30
Overjet Caries Assist-PediatricOverjet, Inc · RadiologyK2337382024-03-04
qXR-LNQure.ai Technologies · RadiologyK2318052023-12-22
Videa Dental AssistVideaHealth, Inc. · RadiologyK2323842023-12-15
Denti.AI DetectDenti.AI Technology, Inc. · RadiologyK2301442023-10-06
DeepTek CXR Analyzer v1.0DeepTek Medical Imaging Pvt Ltd · RadiologyK2310012023-10-05
Lung-CADImagen Technologies, Inc · RadiologyK2300852023-10-03
Overjet Periapical Radiolucency AssistOverjet, Inc · RadiologyK2316782023-09-21
Lung-CADImagen Technologies, Inc · RadiologyK2238112023-09-13
VisiRad XRImidex Inc. · RadiologyK2231332023-08-03
DTX Studio Clinic 3.0Nobel Biocare AB · RadiologyK2219212023-03-28
Overjet Caries AssistOverjet, Inc. · RadiologyK2227462023-03-27
Overjet Calculus AssistOverjet Inc. · RadiologyK2209282022-12-16
Aorta-CADImagen Technologies, Inc · RadiologyK2133532022-09-20
Overjet Caries AssistOverjet, Inc. · RadiologyK2125192022-05-10
Videa Caries AssistVideaHealth, Inc · RadiologyK2137952022-04-21
Second OpinionPearl Inc. · RadiologyK2103652022-03-04
Auto Lung Nodule DetectionSamsung Electronics Co.,Ltd. · RadiologyK2015602021-08-31
Chest-CADImagen Technologies, Inc · RadiologyK2106662021-07-20
PowerLook® Tomo Detection SoftwareiCAD Inc · RadiologyP1600092017-03-24
QVCAD SystemQView Medical, Inc. · RadiologyP1500432016-11-09
SECOND LOOK ™ICAD, INC. · RadiologyP0100342002-01-31
RAPIDSCREEN RS-2000RIVERAIN MEDICAL GROUP · RadiologyP0000412001-07-12
LOGICON CARIES DETECTORCARESTREAM DENTAL LLC · RadiologyP9800251998-09-02
M1000 IMAGECHECKERHologic, Inc. · RadiologyP9700581998-06-26