|
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
|
1. K191864 21HK512D
|
2. K192925 32HL512D
|
3. K201777 31HN713D
|
4. K212295 21HQ513D
|
5. K221061 21HQ613D
|
6. K223423 32HQ713D
|
7. K223789 21HQ513D
|
8. K230845 32HL512D, 31HN713D, 32HQ713D
|
9. K232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
|
10. K232985 24HR513C
|
11. K240130 Medical Monitor (21HQ613D)
|
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
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 |
|
|
|
|