|
|
| Device |
analyzer, medical image |
| Regulation Description |
Medical image analyzer. |
| 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 |
| Product Code | MYN |
| Regulation Number |
892.2070
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| AZMED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BENCH7, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BETTER DIAGNOSTICS AI CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CUBE CLICK, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DEEPTEK MEDICAL IMAGING PVT, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DENTI.AI TECHNOLOGY, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DENTSPLY SIRONA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DGNCT, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EXO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| GLEAMER SAS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| IMAGEN TECHNOLOGIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| IMIDEX, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NOBEL BIOCARE AB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NOBEL BIOCARE C/O MEDICIM NV |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OVERJET, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| PEARL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| QURE.AI TECHNOLOGIES |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SAMSUNG ELECTRONICS CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VELMENI, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| VIDEAHEALTH, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
|
| MDR Year |
MDR Reports |
MDR Events |
| 2024 |
1 |
1 |
| 2025 |
2 |
2 |
|
|
|
|
