MERGE HEALTHCARE SOLUTIONS INC.

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) (6) Computer, Diagnostic, Programmable (DQK) (3) System, Image Management, Ophthalmic (NFJ) (1)

Premarket Exempt

No

Clear

CADstream - 00842000100003 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 Hemo - 00842000100010 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

Merge Hemo - 00842000100027 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

Merge HEMO - 00842000100034 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

Merge Cardio - 00842000100041 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 Unity PACS - 00842000100058 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 Z3D - 00842000100065 Catalog Number :

Device Description : Stand alone software application.

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge PACS - 00842000100072 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 - 00842000100089 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 Eye Care PACS - 00842000100096 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

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