|
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. K183496 JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C ...
|
2. K183499 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
|
3. K190848 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
|
4. K230643 CP620G LCD monitor, CP620 LCD monitor
|
5. K230723 C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
|
6. K230728 JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C6 ...
|
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
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 |
|
|
|
|