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) (10)

Premarket Exempt

Clear

Merge PACS - 00842000100690 Catalog Number :

Device Description : Merge PACS™ is a standards-based medical imaging diagnostic workstation that ser Merge PACS™ is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians’ worklists and retrieving and managing studies for reading, reporting, communication, and storage.Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge OrthoPACS - 00842000100706 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge OrthoCase - 00842000100713 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

IBM iConnect Access - 00842000100720 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge PACS - 00842000100737 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge Unity PACS - 00842000100744 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Merge Cardio V11.1 - 00842000100751 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge Cardio - 00842000100768 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Merge OrthoPACS - 00842000100775 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

IBM iConnect Access - 00842000100782 Catalog Number :

Device Class : 2

Duns Number: 065626069

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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