Product Code: MYN FDA class 2 21 CFR 892.2070

Analyzer, Medical Image

Radiology

The Medical Image Analyzer is a radiology device that uses software algorithms to analyze medical images (such as X-rays, CT scans, or MRI images) and provide interpretive or quantitative outputs to assist clinicians in diagnosis. This device was reclassified to Class 2 as documented in a Federal Register notice from January 2020. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 892.2070 (Radiology specialty).

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MYN
Device Class: FDA class 2
Regulation Number: 892.2070
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252953	Velmeni for Dentists (V4D) Endo-Perio	May 11, 2026	Substantially Equivalent	Velmeni, Inc.
K251934	qXR-Detect	Jan 16, 2026	Substantially Equivalent	Qure.Ai Technologies
K252934	Diagnocat	Jan 15, 2026	Substantially Equivalent	DGNCT, LLC
K253009	DS Core Detect	Jan 07, 2026	Substantially Equivalent	Dentsply Sirona, Inc.
K252086	DTX Studio Assist	Nov 17, 2025	Substantially Equivalent	Nobel Biocare C/O Medicim NV
K250525	Second Opinion® Panoramic	Nov 14, 2025	Substantially Equivalent	Pearl, Inc.
K250264	SugarBug (1.x)	Nov 07, 2025	Substantially Equivalent	Bench7, Inc.
K251002	Videa Dental AI	Sep 19, 2025	Substantially Equivalent	Videahealth, Inc.
K250753	VELMENI for DENTISTS (V4D)	Sep 02, 2025	Substantially Equivalent	Velmeni, Inc.
K243234	Second Opinion® CS	Jun 12, 2025	Substantially Equivalent	Pearl, Inc.
K242437	Smile Dx®	May 14, 2025	Substantially Equivalent	Cube Click, Inc.
K243893	Second Opinion® Pediatric	May 05, 2025	Substantially Equivalent	Pearl, Inc.
K243239	Lung AI (LAI001)	Apr 24, 2025	Substantially Equivalent	Exo, Inc.
K242600	Second Opinion Periapical Radiolucency Contours	Apr 11, 2025	Substantially Equivalent	Pearl, Inc.
K243831	Rayvolve LN	Mar 26, 2025	Substantially Equivalent	AZmed
K241725	Better Diagnostics Caries Assist (BDCA) Version 1.0	Mar 11, 2025	Substantially Equivalent	Better Diagnostics AI Corp.
K241620	ChestView US	Feb 27, 2025	Substantially Equivalent	Gleamer Sas
K242522	Second Opinion CC	Jan 16, 2025	Substantially Equivalent	Pearl, Inc.
K240003	Velmeni for Dentists (V4D)	Aug 30, 2024	Substantially Equivalent	Velmeni, Inc.
K233738	Overjet Caries Assist-Pediatric	Mar 04, 2024	Substantially Equivalent	Overjet, Inc.
K231805	qXR-LN	Dec 22, 2023	Substantially Equivalent	Qure.Ai Technologies
K232384	Videa Dental Assist	Dec 15, 2023	Substantially Equivalent	Videahealth, Inc.
K230144	Denti.AI Detect	Oct 06, 2023	Substantially Equivalent	Denti.Ai Technology, Inc.
K231001	DeepTek CXR Analyzer v1.0	Oct 05, 2023	Substantially Equivalent	Deeptek Medical Imaging Pvt, Ltd.
K230085	Lung-CAD	Oct 03, 2023	Substantially Equivalent	Imagen Technologies, Inc.
K231678	Overjet Periapical Radiolucency Assist	Sep 21, 2023	Substantially Equivalent	Overjet, Inc.
K223811	Lung-CAD	Sep 13, 2023	Substantially Equivalent	Imagen Technologies, Inc.
K223133	VisiRad XR	Aug 03, 2023	Substantially Equivalent	Imidex, Inc.
K221921	DTX Studio Clinic 3.0	Mar 28, 2023	Substantially Equivalent	Nobel Biocare AB
K222746	Overjet Caries Assist	Mar 27, 2023	Substantially Equivalent	Overjet, Inc.
K220928	Overjet Calculus Assist	Dec 16, 2022	Substantially Equivalent	Overjet, Inc.
K213353	Aorta-CAD	Sep 20, 2022	Substantially Equivalent	Imagen Technologies, Inc.
K212519	Overjet Caries Assist	May 10, 2022	Substantially Equivalent	Overjet, Inc.
K213795	Videa Caries Assist	Apr 21, 2022	Substantially Equivalent	Videahealth, Inc.
K210365	Second Opinion	Mar 04, 2022	Substantially Equivalent	Pearl, Inc.
K201560	Auto Lung Nodule Detection	Aug 31, 2021	Substantially Equivalent	Samsung Electronics Co., Ltd.
K210666	Chest-CAD	Jul 20, 2021	Substantially Equivalent	Imagen Technologies, Inc.