HYLAND LLC

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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

Medical Device Data System (OUG) (6) System, Digital Image Communications, Radiological (LMD) (2) System, Image Processing, Radiological (LLZ) (2)

Premarket Exempt

No Yes

Clear

PACSgear Media Writer Web - 00850677007242 Catalog Number :

Device Description : Media Writer Web

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

PACSgear Enterprise Server - 00850677007259 Catalog Number :

Device Description : Core Server

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

EHR-Gateway - 00850677007266 Catalog Number :

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

ModLink Web Forms - 00850677007273 Catalog Number :

Device Description : Web Forms

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

PACS Scan Web - 00850677007280 Catalog Number :

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

Image Link - 00850677007297 Catalog Number :

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

Image Link Encounter Workflow - 00850677007303 Catalog Number :

Device Description : Encounter Manager

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

EHR-Gateway Print - 00850677007310 Catalog Number :

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

GearView QC - 00850677007327 Catalog Number :

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

GearView Basic - 00850677007341 Catalog Number :

Device Class :

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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