FDA.reportPublic FDA data

Diagnostic x-ray digital imaging system workstation

Definition
A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.
GUDID devices
78
Last updated
2026-09-29 04:02:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00198953076873SenoIrisGE MEDICAL SYSTEMS12025-11-24
00850003095011InferRead CT Stroke.AIInfervision US Inc1.1.0.02021-08-18
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPADRF 4343-LT System DT2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPADRF 4343-LT System DT2026-06-04
08057737122217Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPADRF 43432023-08-29
08057737122262Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPADRF 4343 FL2023-08-29
00860008045539X1-FFRSpectrawave, Inc.9912026-05-07
07290017855028FFRangioCATHWORKS LTDFAU010002019-02-12
07290017855059FFRangioCATHWORKS LTDFAU040002019-12-26
D835CDX1coDiagnostiXDental Wings GmbH92016-09-17
D835CODX1coDiagnostiXDental Wings GmbH102021-07-20
00860015011107VMADRIVING FORCE COMPANYVMA3000 Control Console Assembly2026-01-02
00860015011114VMADRIVING FORCE COMPANYVMA1000 Motion Normalizer Upright2026-01-02
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MONITOR CART,IDI W/27IN TOUCH MONITOR,GE OEC ONE2025-11-18
00850061871268IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT CONNECT 272025-07-14
00850061871275IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.ILEX DUO DIRECT PREMIUM 322025-07-14
00850061871282IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.ILEX DUO PLATINUM 322025-07-14
00887517764133LessRayNuvasive, Inc.82300202020-11-16
07290019776000VUZE System 2.0VUZE MEDICAL LTDVM-PK-0012024-10-30
00887517805997LessRayNuvasive, Inc.82300222024-04-05
00887517814135LessRayNuvasive, Inc.82300252024-04-05
08800099500076AXIR-CXRadisen Co., Ltd.AXIR-CX2023-11-15
08057737122361Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPADRF 4343-TS2023-08-29
00850977007737IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MONITOR CART,IDI W/27IN TOUCH SCREEN MONITOR2023-06-07
00850977007928IMAGE DIAGNOSTICS, INC.IMAGE DIAGNOSTICS, INC.MDS, 4K, 120V2023-06-08
D835CODX200coDiagnostiXDental Wings GmbH102021-07-20
00887517811936LessRayNuvasive, Inc.82300232021-06-15
00887517840653LessRayNuvasive, Inc.16756392021-06-15
00887517976062LessRayNuvasive, Inc.82300422021-06-15
00887517992789LessRayNuvasive, Inc.16758992021-06-15
00887517994806LessRayNuvasive, Inc.82300432021-06-15
00887517994813LessRayNuvasive, Inc.82300442021-06-15
00887517994820LessRayNuvasive, Inc.82300452021-06-15
00887517996022LessRayNuvasive, Inc.LRTABLELOANCE2021-06-15
00195278263919Digital Expert AccessGE HEALTHCARE12021-04-07
00850977007669IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.ilex D,4X INPUT 55IN. MONITOR2020-12-07
00850977007676IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.ilex D,1X INPUT 55IN. MONITOR2020-12-07
00840682147767SenoIrisGE MEDICAL SYSTEMS12020-07-01
00887517732675LessRayNuvasive, Inc.82300022017-04-04
00887517732699LessRayNuvasive, Inc.82300042017-04-04
00887517732712LessRayNuvasive, Inc.82300062017-04-04
00887517732729LessRayNuvasive, Inc.82300072017-04-04
00887517756688LessRayNuvasive, Inc.82300092017-04-04
00887517756695LessRayNuvasive, Inc.82300102017-04-04
00887517756701LessRayNuvasive, Inc.82300112017-04-04
00887517756718LessRayNuvasive, Inc.82300122017-04-04
00887517756725LessRayNuvasive, Inc.82300132017-04-04
00887517756732LessRayNuvasive, Inc.82300142017-04-04
00887517756749LessRayNuvasive, Inc.82300152017-04-04
00887517756756LessRayNuvasive, Inc.82300162017-04-04
00887517756763LessRayNuvasive, Inc.82300172017-04-04
00887517756770LessRayNuvasive, Inc.82300182017-04-04
00887517756787LessRayNuvasive, Inc.82300192017-04-04
00887517837363LessRayNuvasive, Inc.82300292017-09-22
00887517948182LessRayNuvasive, Inc.LRCARTMKT2018-09-15
00887517948199LessRayNuvasive, Inc.LRCPUMKT2018-09-15
00887517948304LessRayNuvasive, Inc.LRISOMKT2018-09-15
00887517948311LessRayNuvasive, Inc.LRLRGMONMKT2018-09-15
00887517948328LessRayNuvasive, Inc.LRSMLMONMKT2018-09-15
00840682104395SenolrisGE Healthcare GmbH12016-08-05
D77664556330SICAT SuiteSiCAT GmbH & Co. KG64556332016-08-31
D77664556410SICAT Function SiCAT GmbH & Co. KG64556412016-08-31
D835CDX202coDiagnostiXDental Wings GmbH92016-09-17
17290017855056FFRangioCATHWORKS LTDFAU04002019-12-26
08053470960000C015MICRONICA SRLFP XS C0152020-03-16
08053470960017C015MICRONICA SRLFP XL C0152020-03-16
00840682146555NAGE Hualun Medical Systems Co., Ltd58351652019-10-08
00840682140614SenoIrisGE Healthcare GmbH12019-06-04
B06965436510SICAT AirHiCat GmbH65436512016-08-31
04056869010113syngo X WorkplaceSiemens Healthcare GmbH105025222016-09-24
04056869010120syngo X WorkplaceSiemens Healthcare GmbH102812992016-09-24
04547410316926FCRViewFUJIFILM CORPORATIONCR-VW6742016-09-16
17290017855025FFRangioCATHWORKS LTDFAU010002019-02-12
00868579000209VMAORTHO KINEMATICS, INC.22016-09-22
00868579000247VMA Motion NormalizerORTHO KINEMATICS, INC.32018-01-31
00817100020193Konica Minolta SW (PACS) ExaKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.EXA 01-04-0002016-09-24
00817100020209Konica Minolta SW (PACS) Opal Rad, 20/20 Opal RadKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.OPAL 02-04-04-0002016-09-24
00817100020490Konica Minolta SW (PACS) Opal Rad, 20/20 Opal RadKONICA MINOLTA MEDICAL IMAGING U.S.A., INC.OPAL 02-04-06-0002016-10-18