iScan 700-52800-001

GUDID 00858848006421

Ophthalmic Optical Coherence Tomography System

OPTOVUE, INC.

Spectral-domain optical coherence tomography system
Primary Device ID00858848006421
NIH Device Record Key75c18c66-5da7-4d4e-861e-2753829a903e
Commercial Distribution StatusIn Commercial Distribution
Brand NameiScan
Version Model NumberiVue 500
Catalog Number700-52800-001
Company DUNS196500461
Company NameOPTOVUE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-941-9240
Emailservice@optovue.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858848006421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-31

On-Brand Devices [iScan]

00858848006438Ophthalmic Optical Coherence Tomography System
00858848006421Ophthalmic Optical Coherence Tomography System
00858848006407Ophthalmic Optical Coherence Tomography System
00858848006315iVue 500 System
00858848006018iVue 500 System
00858848006742Ophthalmic Optical Coherence Tomography System
00858848006735Ophthalmic Optical Coherence Tomography System

Trademark Results [iScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISCAN
ISCAN
87462795 not registered Dead/Abandoned
MedTech Specialty Group, Inc.
2017-05-24
ISCAN
ISCAN
86339228 4740891 Live/Registered
Optovue, Inc.
2014-07-16
ISCAN
ISCAN
86247500 4640796 Live/Registered
Humanim, Inc.
2014-04-09
ISCAN
ISCAN
86247458 4640794 Live/Registered
Humanim, Inc.
2014-04-09
ISCAN
ISCAN
86157480 4592235 Live/Registered
LIFESAFETY POWER INC.
2014-01-04
ISCAN
ISCAN
85735654 4338393 Live/Registered
Illumina, Inc.
2012-09-21
ISCAN
ISCAN
85618476 4526316 Live/Registered
Inphi Corporation
2012-05-07
ISCAN
ISCAN
85438741 4243777 Live/Registered
Avision Inc.
2011-10-04
ISCAN
ISCAN
79012014 3253851 Live/Registered
Sivantos GmbH
2005-03-21
ISCAN
ISCAN
78003552 not registered Dead/Abandoned
STOCKDALE, SCOTT
2000-04-11
ISCAN
ISCAN
78003542 not registered Dead/Abandoned
STOCKDALE, SCOTT
2000-04-11
ISCAN
ISCAN
77445376 not registered Dead/Abandoned
Illumina, Inc.
2008-04-10

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