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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, Digital Image Communications, Radiological (LMD) (6)

Premarket Exempt

Yes

Clear

DicomForward - B295DICOMFWD30 Catalog Number :

Device Description : Basic DICOM gateway

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

ConnectWeb with PACSCore - B295FULLPACS30 Catalog Number :

Device Description : ConnectWeb viewer front-end with PACSCore back-end archive

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

PACSCore - B295PACSCORE60 Catalog Number :

Device Description : PACSCore back-end archive

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

ViewBox Advanced - B295VBA10 Catalog Number :

Device Description : Advanced radiologist workstation

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

ViewBox Basic - B295VBB60 Catalog Number :

Device Description : Basic radiologist workstation

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

Vendor Neutral Archive with ConnectWeb - B295VNA70 Catalog Number :

Device Description : PACSCore VNA archive with remote, remote backup, and optional local repositories PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive

Device Class : 1

Duns Number: 080220305

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

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