Device class
Class II
Regulation 892.2070
Total clearances
40
2021-07-20 → 2026-09-09
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
Regulation number
892.2070
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 |
1 |
2026-05-11 |
|
Videahealth, Inc.
|
3 |
0 |
2025-09-19 |
|
Better Diagnostics AI Corp. |
2 |
1 |
2026-07-15 |
|
Qure.Ai Technologies
|
2 |
1 |
2026-01-16 |
|
Gleamer Sas |
1 |
0 |
2025-02-27 |
|
AZmed
|
1 |
0 |
2025-03-26 |
|
DGNCT, LLC |
1 |
1 |
2026-01-15 |
|
Cube Click, Inc. |
1 |
0 |
2025-05-14 |
|
Exo, Inc.
|
1 |
0 |
2025-04-24 |
|
Bench7, Inc. |
1 |
1 |
2025-11-07 |
|
Dentsply Sirona, Inc.
|
1 |
1 |
2026-01-07 |
|
Gleamer
|
1 |
1 |
2026-09-09 |
|
Nobel Biocare C/O Medicim NV |
1 |
1 |
2025-11-17 |
|
Samsung Electronics Co., Ltd.
|
1 |
0 |
2021-08-31 |
|
Denti.Ai Technology, Inc. |
1 |
0 |
2023-10-06 |
|
Nobel Biocare AB
|
1 |
0 |
2023-03-28 |
|
Deeptek Medical Imaging Pvt, Ltd. |
1 |
0 |
2023-10-05 |
|
Imidex, Inc. |
1 |
0 |
2023-08-03 |
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 |
|---|
| 2026-09-09 |
K252486 |
Gleamer
|
ChestView US (1.1) |
| 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 |