MERGE HEALTHCARE SOLUTIONS INC.

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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 Processing, Radiological (LLZ) (8) System, Image Management, Ophthalmic (NFJ) (2) Camera, Ophthalmic, Ac-Powered (HKI) (1)

Premarket Exempt

Clear

Merge iConnect Access - 00842000100126 Catalog Number :

Device Description : Standalone software application.

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

iConnect Enterprise Workflow with Merge PACS - 00842000100133 Catalog Number :

Device Description : Standalone software application. A universal workflow (non-medical tool) on Merg Standalone software application. A universal workflow (non-medical tool) on Merge PACS platform.

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge Eye Station - 00842000100140 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : NFJ, HKI

Prescription Use : Yes

Device Count : 1

eFilm Workstation - 00842000100287 Catalog Number :

Device Description : Standalone software application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

eFilm Lite - 00842000100294 Catalog Number :

Device Description : Standalone software application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

eFilm Lite - 00842000100300 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge Eye Care PACS - 00842000100317 Catalog Number :

Device Description : Standalone software application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : NFJ

Prescription Use : Yes

Device Count : 1

Merge Unity PACS - 00842000100331 Catalog Number :

Device Description : Standalone software application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge OrthoPACS - 00842000100348 Catalog Number :

Device Description : Standalone software application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge PACS - 00842000100409 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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