|
|
| Device |
display, diagnostic radiology |
| Definition |
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. |
| Product Code | PGY |
| Regulation Number |
892.2050
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| BARCO N.V. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BARCO NV |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| BENQ CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EIZO CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
12
|
| JVC KENWOOD CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| JVCKENWOOD CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| LG ELECTRONICS INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
11
|
| NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
|
1. K183492 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C ...
|
|
2. K183494 R190/R191 LCD Monitor
|
|
3. K183497 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M ...
|
|
4. K183498 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
|
|
5. K200742 JUSHA-CP610 LCD Monitor
|
|
6. K212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C121 ...
|
|
7. K222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 L ...
|
|
8. K231170 C350/C350G LCD Monitor; M550/M550G LCD Monitor
|
| NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
8
|
|
1. K183492 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C ...
|
|
2. K183494 R190/R191 LCD Monitor
|
|
3. K183497 JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M ...
|
|
4. K183498 JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
|
|
5. K200742 JUSHA-CP610 LCD Monitor
|
|
6. K212231 C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C121 ...
|
|
7. K222121 C630G LCD monitor, JUSHA-C630G LCD monitor, C630 L ...
|
|
8. K231170 C350/C350G LCD Monitor; M550/M550G LCD Monitor
|
| QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| QINGDAO HISENSE MEDICAL EQUIPMENT CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUANTUM-SPECTRA LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| QUBYX SOFTWARE TECHNOLOGIES INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
7
|
| SHENZHEN BEACON DISPLAY TECHNOLOGY CO.,LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| THE LINDEN GROUP CORP |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| WIDE CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
8
|
|
| MDR Year |
MDR Reports |
MDR Events |
| 2017 |
1 |
1 |
|
| Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
| No Information |
1 |
1 |
|
|
|
|
