|
Device |
system, x-ray, mobile |
Product Code | IZL |
Regulation Number |
892.1720
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AGFA N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K191884 DR 100s
|
ASPENSTATE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARESTREAM HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRGEM CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ENERGY RESOURCES INTERNATIONAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FIRST SOURCE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HDT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIVERMORETECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-X LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-X LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINXRAY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MINXRAY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANO-X IMAGING LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUF INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OXOS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS MEDICAL SYSTEMS DMC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POSKOM CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADMEDIX LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REMEDI CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAMSUNG ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SEDECAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SEDECAL, SA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEDECAL., SA. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI) |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SHENZHEN BROWINER TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKANRAY TECHNOLOGIES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEPHANIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU POWERSITE ELECTRIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VATECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VMI TECNOLOGIAS LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VSI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|