MYN · Analyzer, Medical Image · Chrysalis Intelligence

Device class

Class II

Regulation 892.2070

Total clearances

2021-07-20 → 2026-08-06

Last 12 months

Unique sponsors

Definition

What is Analyzer, Medical Image

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

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.2070

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Pearl, Inc.	6	1	2025-11-14
Overjet, Inc.	6	1	2026-08-06
Imagen Technologies, Inc.	4	0	2023-10-03
Velmeni, Inc.	3	2	2026-05-11
Videahealth, Inc.	3	1	2025-09-19
Better Diagnostics AI Corp.	2	1	2026-07-15
Qure.Ai Technologies	2	1	2026-01-16
AZmed	1	0	2025-03-26
DGNCT, LLC	1	1	2026-01-15
Nobel Biocare C/O Medicim NV	1	1	2025-11-17
Imidex, Inc.	1	0	2023-08-03
Deeptek Medical Imaging Pvt, Ltd.	1	0	2023-10-05
Bench7, Inc.	1	1	2025-11-07
Cube Click, Inc.	1	0	2025-05-14
Exo, Inc.	1	0	2025-04-24
Samsung Electronics Co., Ltd.	1	0	2021-08-31
Gleamer Sas	1	0	2025-02-27
Denti.Ai Technology, Inc.	1	0	2023-10-06
Dentsply Sirona, Inc.	1	1	2026-01-07
Nobel Biocare AB	1	0	2023-03-28

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
70553	CPT	—	Low	Medical image analyzer billed as component of imaging studies; specific code depends on modality

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-06	K261059	Overjet, Inc.	Overjet Multi-Image Caries and Charting Assist
2026-07-15	K260851	Better Diagnostics AI Corp.	Better Diagnostics Dental Assist (BDDA) Version 1.0
2026-05-11	K252953	Velmeni, Inc.	Velmeni for Dentists (V4D) Endo-Perio
2026-01-16	K251934	Qure.Ai Technologies	qXR-Detect
2026-01-15	K252934	DGNCT, LLC	Diagnocat
2026-01-07	K253009	Dentsply Sirona, Inc.	DS Core Detect
2025-11-17	K252086	Nobel Biocare C/O Medicim NV	DTX Studio Assist
2025-11-14	K250525	Pearl, Inc.	Second Opinion® Panoramic
2025-11-07	K250264	Bench7, Inc.	SugarBug (1.x)
2025-09-19	K251002	Videahealth, Inc.	Videa Dental AI
2025-09-02	K250753	Velmeni, Inc.	VELMENI for DENTISTS (V4D)
2025-06-12	K243234	Pearl, Inc.	Second Opinion® CS
2025-05-14	K242437	Cube Click, Inc.	Smile Dx®
2025-05-05	K243893	Pearl, Inc.	Second Opinion® Pediatric
2025-04-24	K243239	Exo, Inc.	Lung AI (LAI001)
2025-04-11	K242600	Pearl, Inc.	Second Opinion Periapical Radiolucency Contours
2025-03-26	K243831	AZmed	Rayvolve LN
2025-03-11	K241725	Better Diagnostics AI Corp.	Better Diagnostics Caries Assist (BDCA) Version 1.0
2025-02-27	K241620	Gleamer Sas	ChestView US
2025-01-16	K242522	Pearl, Inc.	Second Opinion CC
2024-08-30	K240003	Velmeni, Inc.	Velmeni for Dentists (V4D)
2024-03-04	K233738	Overjet, Inc.	Overjet Caries Assist-Pediatric
2023-12-22	K231805	Qure.Ai Technologies	qXR-LN
2023-12-15	K232384	Videahealth, Inc.	Videa Dental Assist
2023-10-06	K230144	Denti.Ai Technology, Inc.	Denti.AI Detect