FDA.reportPublic FDA data

Dicom Box

Primary DI
00850677007037
Brand
Dicom Box
Company
HYLAND LLC
Model
1
Device description
Dicom Box Image Acquisition Unit
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMADigitizer, Image, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMADigitizer, Image, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954875000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954875000ASPECT ACQUISITION MODULE (AAM)Aspect Electronics, Inc.1996-01-02LMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850677007037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850677007037008506770070378506770070370850677007037

GMDN Terms#

Term, Definition table
TermDefinition
Radiography digital imaging scannerA laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079941872
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850677007129Media Writer52019-03-12
00850677007136Media Writer CD52019-03-12
00850677007327GearView QC3X2020-09-30
00850677007396PACSgear Enterprise Server5.1.X2020-11-13
00850677007389Image Link Plus1.X2021-02-26
00850677007419PACSgear Enterprise Server5.2.XCS.5.22021-02-26
00850677007341GearView Basic3X2020-09-30
00850677007259PACSgear Enterprise Server5.X2020-04-10
00850677007266EHR-Gateway 3.X2020-04-10
00850677007273ModLink Web Forms4.X2020-04-10
00850677007280PACS Scan Web3.X2020-04-10
00850677007297Image Link3.X2020-04-10
00850677007303Image Link Encounter Workflow2.X2020-04-10
00850677007310EHR-Gateway Print 2.X2020-04-10
00850677007150PACS Scan Mobile2.2.XPSM2.2.22019-12-27
00850677007167PACSgear Core Server4.X2019-12-27
00850677007181PACSgear PACS Scan Web2.X2019-12-27
00850677007198PACSgear Image Link2.X2019-12-27
00850677007204PACSgear Image Link Encounter Workflow1.X2019-12-27
00850677007211PACSgear Mod Link3.X2019-12-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481140502Patient Data ManagerBrainlab SELMA2018-06-15
04056481138615PATIENT DATA MANAGER 2.4 INSTALLERBrainlab SELMA2018-02-09
04056481132453Origin Data Management / Patient Data ManagerBrainlab SELMA2017-01-02
00850677007082MDR Video TouchHYLAND LLCLMA2016-09-26
00851194002000Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002017Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002031Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002048Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002093Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002109Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002116Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002123Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002130Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00851194002147Vidar Systems CorporationVIDAR SYSTEMS CORPORATIONLMA2016-09-25
00866389000167Radlink Laser Pro 16RADLINK, INC.LMA2016-09-21
00850677007068MDR Video CartHYLAND LLCLMA2016-09-19
00850677007075MDR Video SpeechHYLAND LLCLMA2016-09-19
00850677007020MDR VideoHYLAND LLCLMA2016-09-16
04056481006662Origin Data Management / Patient Data ManagerBrainlab SELMA2016-09-15