FDA.reportPublic FDA data

Visix

Primary DI
00851800007092
Brand
Visix
Company
TELEVERE SYSTEMS, LLC
Model
for Intraoral Camera 2.3.10
Catalog number
Visix for Intraoral Camera 2.3.10
Device description
Visix software for use with just an intraoral camera version 2.3.10
Published
2016-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082623000VISIX IMAGINGTelevere Systems2009-02-25LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851800007092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851800007092008518000070928518000070920851800007092

GMDN Terms#

Term, Definition table
TermDefinition
Camera application softwareA data program designed for use in, or together with, a camera (e.g., a digital camera or video recorder) so that it may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
518-243-9705barb@tigerview.com

Regulatory Flags#

DUNS number
127132269
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851800007139TigerView8.6TigerView 8.62026-05-09
00851800007108TigerView8.4.1TigerView 8.4.12021-10-01
00851800007009TigerView7.7.13TigerView Pro 7.7.132016-09-27
00851800007016TigerView8.1 Build 81TigerView 8.1 Build 812016-09-27
00851800007023TigerView7.7.3TigerView Pro 7.7.32016-09-27
00851800007030Visix2.3.9Visix 2.3.92016-09-27
00851800007047Visix7.7.15Visix Pro 7.7.152016-09-27
00851800007054Visix8.1 Build 81Visix 8.1 Build 812016-09-27
00851800007061TigerView8.3TigerView 8.32018-06-22
00851800007078ExamVue PACS1.1 Build 81ExamVue PACS 1.1 Build 812016-10-10
00851800007085TigerView8.2TigerView 8.22018-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800010500840SonoSync+SAMSUNG MEDISON CO., LTD.LLZ2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-08-18
B359OAIIV2026071RamSoftRamsoft IncLLZ2026-08-17
00850631008896Roentgen WorksBrit Systems, LLCLLZ2026-08-14
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00860011624349IntraOpVSPXironetic LLCLLZ2026-08-03
00862234000337Mosaic ViewerVirtual Radiologic CorporationLLZ2026-07-31
09358140000093Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-07-30
00866463000496STAGESpintech, Inc.LLZ2026-07-23
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
17540262090161Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-07-21
M722CP26183V261830ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-07-17
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10