FDA.reportPublic FDA data

Stationary basic diagnostic x-ray system, digital

Definition
An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
GUDID devices
701
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00198953054949NAGE Hualun Medical Systems Co., LtdGCTS-C112025-09-30
00198953056103DefiniumGE Hualun Medical Systems Co., LtdPace Select ET2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdTempo Select2026-02-12
00810030350071uDRUIH TECHNOLOGIES LLCuDR 780i2020-05-26
00810035220386Radmedix AcuityFDRRADMEDIX, LLC12020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLC12020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLC12020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLC12020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLC12020-09-18
00860001668605Insight Essentials DRFImaging Engineering, LLCInsight Essentials DRF2026-05-21
00860001668612Insight Enhanced DRFImaging Engineering, LLCInsight Enhanced DRF2026-05-21
00860001668636Insight Agile DRFImaging Engineering, LLCInsight Agile DRF2026-05-21
04719879300017YushanINNOCARE OPTOELECTRONICS CORPORATIONV14C2020-11-03
04719879300024YushanINNOCARE OPTOELECTRONICS CORPORATIONV14G2020-11-03
04719879300031YushanINNOCARE OPTOELECTRONICS CORPORATIONV17C2020-11-03
04719879300048YushanINNOCARE OPTOELECTRONICS CORPORATIONV17G2020-11-03
04719879300055YushanINNOCARE OPTOELECTRONICS CORPORATIONV17Ge2020-11-03
06009880828135LODOXLODOX SYSTEMS (PTY) LTDXmplar-dr2020-11-04
06971576833689uDRShanghai United Imaging Healthcare Co., Ltd.uDR Aurora CX2025-11-19
08436046000940SEDECALSEDECALSEDECAL X PLUS LP2016-10-28
08436046000964SEDECALSEDECALSEDECAL X PLUS (LP) PLUS2016-10-28
08436046001176SEDECALSEDECALMILLENIUM PLUS TPC2016-10-31
08436046002050SEDECALSEDECALMILLENNIUM (Proteus XR/i)2016-10-31
08436046002128SEDECALSEDECALRAD SYSTEM NOVA FA2016-10-31
08436046002135SEDECALSEDECALRAD SYSTEM NOVA AT2016-10-31
08436046002142SEDECALSEDECALRAD SYSTEM NOVA ST2016-10-31
08436046002319SEDECALSEDECALProteus XR/f AT2017-02-15
08436046002333SEDECALSEDECALMILLENNIUM2018-05-01
08436046002340SEDECALSEDECALMULTIRAD2018-05-01
08606102809101VISIONVISARIS DOOVision C2016-10-11
08606102809118VISIONVISARIS DOOVision U2016-10-13
08606102809125VISIONVISARIS DOOVision X2016-10-13
08606102809132VISIONVISARIS DOOVision V2016-10-13
08800011140021DRGEMDRGEM CorporationDIAMOND-8A2017-05-29
08800011140175DRGEMDRGEM CorporationDIAMOND-8A2017-05-29
08800011140403DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140410DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140427DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140434DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140441DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140458DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140465DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140472DRGEMDRGEM CorporationSGXR-32SD2019-01-07
08800011140489DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140496DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140502DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140519DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140526DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140533DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140540DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140557DRGEMDRGEM CorporationSGXR-40SD2019-01-07
08800011140564DRGEMDRGEM CorporationSGXR-52SD2019-01-07
08800011140571DRGEMDRGEM CorporationSGXR-52SD2019-01-07
08800011140588DRGEMDRGEM CorporationSGXR-52SD2019-01-07
08800011140595DRGEMDRGEM CorporationSGXR-68SD2019-01-07
08800011140601DRGEMDRGEM CorporationSGXR-68SD2019-01-07
08800011140618DRGEMDRGEM CorporationSGXR-68SD2019-01-07
08800011140625DRGEMDRGEM CorporationSGXR-82SD2019-01-07
08800011140632DRGEMDRGEM CorporationSGXR-82SD2019-01-07
08800011140649DRGEMDRGEM CorporationSGXR-82SD2019-01-07
08800011140656DRGEMDRGEM CorporationSGXR-C32SD2019-01-07
08800011140663DRGEMDRGEM CorporationSGXR-C32SD2019-01-07
08800011140670DRGEMDRGEM CorporationSGXR-C32SD2019-01-07
08800011140687DRGEMDRGEM CorporationSGXR-C32SD2019-01-07
08800011140694DRGEMDRGEM CorporationSGXR-C40SD2019-01-07
08800011140700DRGEMDRGEM CorporationSGXR-C40SD2019-01-07
08800011140717DRGEMDRGEM CorporationSGXR-C40SD2019-01-07
08800011140724DRGEMDRGEM CorporationSGXR-C40SD2019-01-07
08800011140731DRGEMDRGEM CorporationSGXR-C52SD2019-01-07
08800011140748DRGEMDRGEM CorporationSGXR-C52SD2019-01-07
08800011140755DRGEMDRGEM CorporationSGXR-C52SD2019-01-07
08800011140762DRGEMDRGEM CorporationSGXR-C52SD2019-01-07
08800011140779DRGEMDRGEM CorporationSGXR-U32SD2019-01-07
08800011140786DRGEMDRGEM CorporationSGXR-U32SD2019-01-07
08800011140793DRGEMDRGEM CorporationSGXR-U40SD2019-01-07
08800011140809DRGEMDRGEM CorporationSGXR-U40SD2019-01-07
08806086403467NASamsung Electronics Co., Ltd.GC802016-10-31
08806088566313NASamsung Electronics Co., Ltd.GU60A2016-09-24
08809365280001SG HealthcareSG Healthcare Co., Ltd.Jumong2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.Jumong General2026-04-24