FDA.reportPublic FDA data

PACSCore

Primary DI
B295PACSCORE60
Brand
PACSCore
Company
Radius
Model
6
Device description
PACSCore back-end archive
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B295PACSCORE60PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system digital archive deviceA mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080220305
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B295VNA70Vendor Neutral Archive with ConnectWeb72019-07-31
B295FULLPACS30ConnectWeb with PACSCore32016-09-19
B295VBA10ViewBox Advanced12016-09-19
B295VBB60ViewBox Basic62016-09-19
B295DICOMFWD30DicomForward32019-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-09-21
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
05415334059139BarcoBarco NVLMD2026-09-21
05415334059924BarcoBarco NVLMD2026-09-21
05415334059931BarcoBarco NVLMD2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00628105001182Vitrea ReadCanon Medical Informatics A/SLMD2025-04-04
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00628105001168Vitrea ReadCanon Medical Informatics A/SLMD2025-01-10
00628105001175Vitrea ReadCanon Medical Informatics A/SLMD2025-01-10
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00628105001151Vitrea ReadCanon Medical Informatics A/SLMD2024-05-22
00628105001144Vitrea ReadCanon Medical Informatics A/SLMD2024-04-03
00628105001106Vitrea ReadCanon Medical Informatics A/SLMD2024-01-19
00628105001120Vitrea ReadCanon Medical Informatics A/SLMD2024-01-19
00628105001137Vitrea ReadCanon Medical Informatics A/SLMD2023-11-28
00628105001113Vitrea ReadCanon Medical Informatics A/SLMD2023-11-08