|
Device |
camera, ophthalmic, ac-powered |
Product Code | HKI |
Regulation Number |
886.1120
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
C.S.O. S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON COMPONENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CANON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CANON, INC.-MEDICAL EQUIPMENT GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CENTERVUE SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHONGQING BIO NEWVISION MEDICAL EQUIPMENT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARITY MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CRYSTALVUE MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EYENEZ LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EYEQUICK.LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FORUS HEALTH PVT. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUNDUS PHOTO, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUVITZ CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ILOODA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMEDOS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ISCREEN VISION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KEELER LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOWA CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
KOWA COMPANY, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LUNEAU TECHNOLOGY OPERATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NATUS MEDICAL INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOLIGHT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXT SIGHT SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIDEK CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIDEK CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIDEK TECHNOLOGIES SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPHTHALMIC IMAGING SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTINA DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTINA DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTOMED OY |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
OPTOMED OYJ |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTOVUE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHELCOM TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHOENIX TECHNOLOGY GROUP, INC. DBA PHOENIX CLINICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOFTCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEARSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TOPCON CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TOPCON CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOPCON MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRUEVISION SYSTEMS, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED INTEGRATED SERVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASOPTIC MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELCH ALLYN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZILIA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|