TigerView

Primary DI
00851800007016
Brand
TigerView
Company
TELEVERE SYSTEMS, LLC
Model
8.1 Build 81
Catalog number
TigerView 8.1 Build 81
Device description
TigerView 8.1 software Build 81
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K061035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061035000TIGERVIEW PROFESSIONALTelevere Systems2006-06-05LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851800007016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851800007016008518000070168518000070160851800007016

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

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

Regulatory Flags#

DUNS number
127132269
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00851800007092Visixfor Intraoral Camera 2.3.10Visix for Intraoral Camera 2.3.102016-10-10

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Primary DI, Brand, Company table
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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