FDA.reportPublic FDA data

ECHOPIXEL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115013613011501361ECHOPIXEL, INC.1N2026-01-01780 Montague Expy Ste 305 San Jose CA US 95131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851325007003True 3D Viewer - 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.1-844-273-7766salesops@echopixeltech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1806191021400262K201365True 3D ViewerLLZ2020-07-17
1806191498081647K193149True 3D Viewer SoftwareLLZ2019-12-27
1806191640012784K170167True 3D Viewer SoftwareLLZ2017-03-03
1806191312516142K142107ECHO TRUE 3D VIEWERLLZ2015-01-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ42020-07-17

PMN#

GUDID#

True 3D Viewer - 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.

ECHOPIXEL, INC.

2016-10-11