APTERYX 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) (6)

Premarket Exempt

Clear

XrayVision - 00685031000009 Catalog Number :

Device Description : Dental imaging capture, enhance and display software.

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

XVlite - 00685031000016 Catalog Number :

Device Description : Dental imaging capture, enhance and display software.

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

XrayVision DCV - 00685031000023 Catalog Number :

Device Description : Dental imaging capture, enhance and display software.

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

XVCapture - 00685031000030 Catalog Number :

Device Description : Dental imaging capture, enhance and display software for XVWeb.

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

XVWeb - 00685031000047 Catalog Number :

Device Description : A cloud-based, PACS-server software application that gives dental organizations A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

XVWeb - 00685031000054 Catalog Number :

Device Class : 2

Duns Number: 958821886

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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