FDA.reportPublic FDA data

Hermia Gold

Primary DI
00859873006066
Brand
Hermia Gold
Company
Hermes Medical Solutions AB
Model
00859873006066
Device description
GOLD LX is a client-server image storage and communication system whose intended use is toprovide solutions for hospital and related institutions/sites, which will store, retrieve, anddistribute medical images and data from vendor modalities and hospital information systems.
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859873006011PreviousGS10
00859873006066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859873006011008598730060118598730060110859873006011
00859873006066008598730060668598730060660859873006066

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Regulatory Flags#

DUNS number
354140220
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859873006219Hermia OLINDA008598730062192026-03-10
00859873006240Hermia008598730062402026-03-05
00859873006189Hermia008598730061892024-12-10
00859873006172Hermia Multimodality Viewer008598730061722023-07-03
00859873006158Hermes Medical Imaging Suite008598730061582022-02-07
00859873006165Affinity008598730061652022-02-07
00859873006110Voxel Dosimetry008598730061102019-10-28
00859873006035OLINDA/EXM008598730060352017-08-21
00859873006059Hermes Medical Imaging Suite008598730060592017-12-08
00859873006073Hybrid3D008598730060732017-12-08
00859873006080Hermia Gold008598730060802017-11-30
00859873006226Hermia008598730062262025-08-27
00859873006141Affinity2.02021-01-11
00859873006134Affinity1.02020-02-25
00859873006004HMS Medical Imaging Suite5.62016-09-19
00859873006028GOLD SMART WSv1.72016-10-20
00859873006042Hybrid 3D1.0P542017-06-05
00859873006011GOLD Lx1.62016-09-20

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EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
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00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
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05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21