ECHOPIXEL, INC.

Address:4677 Old Ironsides Drive, Suite 445,Santa Clara,CA,95054,US

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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

Clear

True 3D Viewer - 00851325007003 Catalog Number : SW-0001-1601

Device Description : Software: The True 3D Viewer Software is intended for processing, review, analys Software: The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.

Device Class : 2

Duns Number: 079890297

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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