HYLAND LLC

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

Digitizer, Image, Radiological (LMA) (5) System, Image Processing, Radiological (LLZ) (4) System, Digital Image Communications, Radiological (LMD) (1)

Premarket Exempt

No Yes

Clear

PACS Scan - 00850677007006 Catalog Number :

Device Description : PACS Scan Software

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

MDR Video - 00850677007020 Catalog Number :

Device Description : MDR Video Image Acquisition

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LMA

Prescription Use : No

Device Count : 1

Dicom Box - 00850677007037 Catalog Number :

Device Description : Dicom Box Image Acquisition Unit

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LMA

Prescription Use : No

Device Count : 1

Gearview QC - 00850677007051 Catalog Number :

Device Description : Gearview QC Software

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

MDR Video Cart - 00850677007068 Catalog Number :

Device Description : Cart for the MDR Video

Device Class : 2

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMA

Prescription Use : No

Device Count : 1

MDR Video Speech - 00850677007075 Catalog Number :

Device Description : Speech for the MDR Video

Device Class : 2

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMA

Prescription Use : No

Device Count : 1

MDR Video Touch - 00850677007082 Catalog Number :

Device Description : Video Touch 4K

Device Class : 2

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMA

Prescription Use : No

Device Count : 1

GEAR VIEW QC CD - 00850677007105 Catalog Number :

Device Description : GEAR VIEW QC CD

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

PACS Scan CD - 00850677007112 Catalog Number :

Device Description : PACS Scan Software CD

Device Class : 2

Duns Number: 079941872

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Media Writer - 00850677007129 Catalog Number :

Device Description : Media Writer Software

Device Class : 1

Duns Number: 079941872

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

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