EIGEN

FDA Device Registration & Listing · Grass Valley, CA, US · Registration 2937707

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2937707
FEI Number
2937707
Entity Name
EIGEN
City/State/Country
Grass Valley, CA, US
Establishment Address
13366 Grass Valley Ave, Suite A, Grass Valley, CA 95945, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Eigen (Owner Number: 2937707)
Owner / Operator Contact Address
13366 GRASS VALLEY AVE.Suite A, --, Grass Valley, CA 95945, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K120187
PMA Number
N/A

All Registered Proprietary Names

ProFuse / ProFuse CAD Artemis ProFuse

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-04-22
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2017-03-31
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2012-05-01

Official Correspondent

William Mandel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eigen
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23
K961871 Siemens Medical Solutions USA, Inc. FLOUROSPOT T.O.P. 1996-07-31
K122260 Aycan Digitalsysteme GmbH AYCAN MOBILE 2012-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2937707. Last updated year: 2026. Please use registration number 2937707 when referencing this establishment in official correspondence.
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