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) (9) System, Image Management, Ophthalmic (NFJ) (1)

Premarket Exempt

Clear

Merge OrthoPACS - 00842000100577 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 - 00842000100584 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 Cardio - 00842000100591 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 - 00842000100607 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

RadSuite - 00842000100614 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

CADstream - 00842000100638 Catalog Number :

Device Description : Standalone Software Application

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge iConnect Access - 00842000100645 Catalog Number :

Device Description : Software application that provides internet access to multi-modality softcopy me Software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

eFilm Workstation - 00842000100652 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge OrthoPACS - 00842000100676 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

iConnect Access - 00842000100683 Catalog Number :

Device Description : Stand alone software application.

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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