FDA.reportPublic FDA data

Will3D

Primary DI
08800005200144
Brand
Will3D
Company
HDX WILL CORP.
Model
Will3D
Device description
The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
Published
2017-12-22
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
K170180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170180000Will3DHdx Will Corp.2017-05-08LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800005200144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800005200144088000052001448800005200144

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+82215882754global@hdx.co.kr

Regulatory Flags#

DUNS number
689605054
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
08800005200410DENTRI MaxDENTRIα2022-04-29
08800005200427DENTRI MaxDENTRI-Cα2022-04-29
08800005200434DENTRI MaxDENTRI-Sα2022-04-29
08800005200199eco-x serieseco-x2022-02-21
08800005200205eco-x serieseco-x-s2022-02-21
08800005200380DENTRIα seriesDENTRIα2022-02-09
08800005200397DENTRIα seriesDENTRI-Cα2022-02-09
08800005200403DENTRIα seriesDENTRI-Sα2022-02-09
08800005200021DENTRIα SeriesDENTRIα2016-12-25
08800005200038DENTRIα SeriesDENTRI-Cα2016-12-25
08800005200045DENTRIα SeriesDENTRI-Sα2016-12-16
08800005200113DENTIOIII seriesDENTIOIII2019-03-04
08800005200120DENTIOIII seriesDENTIOIII-S2019-03-04
08800005200168WillCephWillCeph2018-05-03
08800005200298Will3DWill3D2021-12-21
08800005200151STAR-XSTAR-X2021-04-28
08800005200175XcamXcam2021-04-28
08800005200182Real ArchReal Arch2021-01-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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