ALTARAVISION, INC.

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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, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

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NDOHD High Definition Imaging System (NDOHD) - 00866861000203 Catalog Number :

Device Description : The NDOHD system is intended for viewing, acquiring, recording, archiving and re The NDOHD system is intended for viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic surgical procedures including, but not limited to, orthoscopic, gynecological, laparoscopic, urologic, sinuscopic procedures. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device. The NDOHD system is not intended to be used in an environment that requires sterilization.

Device Class : 2

Duns Number: 064561659

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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