TOPCON HEALTHCARE SOLUTIONS, INC.

Address:111 Bauer Drive,Oakland,NJ,07436,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Management, Ophthalmic (NFJ) (10) Camera, Ophthalmic, Ac-Powered (HKI) (4) Tomography, Optical Coherence (OBO) (4)

Premarket Exempt

Clear

IMAGEnet 6 - 00850003069005 Catalog Number :

Device Description : The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the co The IMAGEnet 6 ver. 2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ, HKI, OBO

Prescription Use : Yes

Device Count : 1

Harmony - 00850003069012 Catalog Number :

Device Description : Harmony 5.03 is a comprehensive software platform intended for use in importing, Harmony 5.03 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

IMAGEnet 6 - 00850003069029 Catalog Number :

Device Description : The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.0.2 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : OBO, HKI, NFJ

Prescription Use : Yes

Device Count : 1

Synergy ODM - 00850003069036 Catalog Number :

Device Description : Synergy ODM 4.10.500 is a comprehensive software platform intended for use in im Synergy ODM 4.10.500 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

Harmony - 00850003069043 Catalog Number :

Device Description : Harmony 5.04 is a comprehensive software platform intended for use in importing, Harmony 5.04 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

IMAGEnet 6 - 00850003069050 Catalog Number :

Device Description : The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.0.3 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ, HKI, OBO

Prescription Use : Yes

Device Count : 1

IMAGEnet 6 - 00850003069074 Catalog Number :

Device Description : The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the The IMAGEnet 6 ver. 2.1.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : OBO, HKI, NFJ

Prescription Use : Yes

Device Count : 1

Synergy ODM - 00850003069081 Catalog Number :

Device Description : Synergy ODM 4.09.500 is a comprehensive software platform intended for use in im Synergy ODM 4.09.500 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

Harmony - 00850003069098 Catalog Number :

Device Description : Harmony 5.03.200 is a comprehensive software platform intended for use in import Harmony 5.03.200 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

Harmony - 00850003069111 Catalog Number :

Device Description : Harmony 5.05 is a comprehensive software platform intended for use in importing, Harmony 5.05 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.

Device Class : 2

Duns Number: 081155097

Premarket Exempt : No

Product Code : NFJ

Prescription Use : No

Device Count : 1

Previous 1 2 3 Next