FDA.report

Image segmentation application software

Definition
An application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.
GUDID devices
44
Last updated
2026-02-18 22:30:14

Related Product Codes

CodeDeviceSpecialtyClassDevices
LLZSystem, Image Processing, RadiologicalRadiology219
QIHAutomated Radiological Image Processing SoftwareRadiology213
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology25
JAKSystem, X-Ray, Tomography, ComputedRadiology22
KPSSystem, Tomography, Computed, EmissionRadiology22
HAWNeurological Stereotaxic InstrumentNeurology21
LMDSystem, Digital Image Communications, RadiologicalRadiology11
QKBRadiological Image Processing Software For Radiation TherapyRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00860009223660Neosoma Brain MetsNeosoma, Inc.12026-02-10
30815112021543HeartSee Cardiac PET Processing SoftwareBracco Diagnostics Inc.42025-07-25
30815112020584HeartSee Cardiac PET Processing SoftwareBracco Diagnostics Inc.1.002019-07-29
04260483290282MeVis Liver SuiteMeVis Medical Solutions AG1.3.2-IT2025-04-25
00860009223653Neosoma GliomaNeosoma, Inc.22025-03-20
00886874123676IRISEGINTUITIVE SURGICAL, INC.6107002025-02-26
06429830064206Contour+ (MVision AI Segmentation) Mvision AI Oy1.22024-12-31
00861625000437Ceevra Reveal 3+ Ceevra, Inc.3+2024-08-09
03770019599037inHEART Models ShaperINHEARTv1.4.02022-12-12
B973PREOPSHOULDER0ProVoyance PreOp ShoulderGenesis Software Innovations LLC22024-05-31
03770019599075inHEART MODELS AIINHEARTv1.1.02024-04-09
03770019599082inHEART MODELS ShaperINHEARTv1.8.02024-04-08
04260483290268MeVis Liver SuiteMeVis Medical Solutions AG1.32024-01-15
00860009223646Neosoma DashboardNeosoma, Inc.32023-11-14
07350010100041Segment 3DPrintMedviso AB12023-10-31
00860009223608Neosoma HGGNeosoma, Inc.2.1.2.02022-12-22
00860009223615Neosoma DashboardNeosoma, Inc.2.3.2.02022-12-22
03665134000929MrDrawKOELISKURO-40002023-10-02
00860009223622Neosoma DashboardNeosoma, Inc.22023-09-06
00860009223639Neosoma HGGNeosoma, Inc.22023-09-06
00086162500046Reveal 2.0Ceevra, Inc.2.102023-07-07
00850359007966ClearPoint MaestroCLEARPOINT NEURO, INC.CPM-SFW-12022-10-04
B973PREVIEWSHOULDER0PreviewGenesis Software Innovations LLC1.29.12022-09-27
05700002060471Neuroreader Brainreader ApS2.72022-08-22
03665134000714PROMAP – 3D PROSTATE SUITEKOELISKSOF-26022022-07-21
05700002060464Neuroreader Brainreader ApS2.62021-06-28
03770019599013inHEART Models ShaperINHEARTv1.2.02021-04-06
00860000606189BrainInsightHYPERFINE RESEARCH, INC.Version 1.02021-03-05
05700002060457NeuroreaderBrainreader ApS2.52020-12-14
00816847021470D2P3D SYSTEMS, INC.1.0.22020-08-03
00816847022569D2P3D SYSTEMS, INC.1.0.22020-08-03
03665134000585MR DRAWKOELISKURO-40002020-07-23
05057078000024neuroinspire RENISHAW P L CA-5630-30082019-11-15
00886874117507IrisINTUITIVE SURGICAL, INC.3755002019-06-13
00886874117538IrisINTUITIVE SURGICAL, INC.6100402019-06-13
05700002060402NeuroreaderBrainreader ApS2.2.82016-09-23
05700002060419NeuroreaderBrainreader ApS2.2.92017-05-04
05700002060433NeuroreaderBrainreader ApS2.32017-09-07
05700002060440NeuroreaderBrainreader ApS2.42018-09-11
00885556604151DYONICSSmith & Nephew, Inc.722043312015-10-22
00885556604168DYONICSSmith & Nephew, Inc.722043322015-10-22
00885556604175DYONICSSmith & Nephew, Inc.722043332015-10-22
00885556604182DYONICSSmith & Nephew, Inc.722043872015-10-22
00885556604199DYONICSSmith & Nephew, Inc.722043882015-10-22