System, image processing, radiological

FDA product code LLZ · Class 2 · 162 devices · 1,194 reports · 6 deaths reported · 95 devices named in recalls

• OPSInsight™ 1.2

  Optimized Ortho Pty Ltd · System, Image Processing, Radiological
  28 reports
• Merge Unity PACS 11.1.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  18 reports
• IntelliSpace Cardiovascular 4.2

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  17 reports
• Merge Unity PACS 12.0

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  11 reports
• CADstream 6.5

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  11 reports
• INTELEPACS 5

  Les Systèmes Médicaux Intelerad Incorporée · System, Image Processing, Radiological
  9 reports
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 4.1

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  8 reports
• VSP System Mandible Marking Guide

  3d Systems, Inc. · System, Image Processing, Radiological
  7 reports
• VSP System Final Surgical Splint

  3d Systems, Inc. · System, Image Processing, Radiological
  6 reports
• Merge Unity Pacs 11.0

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  6 reports
• Heartflow Analysis 4.x

  Heartflow, Inc. · System, Image Processing, Radiological
  5 reports
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 3.1

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  5 reports
• IntelliSpace Cardiovascular 3.2

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  5 reports
• Affiniti CVx Diagnostic Ultrasound System 795190

  Philips Ultrasound LLC · System, Image Processing, Radiological
  5 reports
• TOMTEC-ARENA TTA2

  TOMTEC Imaging Systems GmbH · System, Image Processing, Radiological
  5 reports
• VELYS 451580051

  Depuy (Ireland) · System, image processing, radiological
  5 reports
• Merge Unity PACS 11.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  4 reports
• Affiniti 50 Ultrasound System 795208

  Philips Ultrasound LLC · System, Image Processing, Radiological
  3 reports
• Arthrex® AR-5400-15

  Arthrex, Inc. · System, image processing, radiological
  3 reports
• Arthrex® AR-5400-18

  Arthrex, Inc. · System, image processing, radiological
  3 reports
• LungVision System Core

  Body Vision Medical Ltd · System, Image Processing, Radiological
  3 reports
• VSP System Surgical Splint

  3d Systems, Inc. · System, Image Processing, Radiological
  2 reports
• Konica Minolta SW (PACS) Exa EXA 01-04-000

  Konica Minolta Medical Imaging U.S.A., Inc. · System, Image Processing, Radiological
  2 reports
• CADstream 6.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 reports
• IBM iConnect Access 8.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  2 reports
• Cleerly Labs v2.0

  Cleerly, Inc. · System, Image Processing, Radiological
  2 reports
• Arthrex® AR-5410-01

  Arthrex, Inc. · System, image processing, radiological
  2 reports
• IMPAX 6

  Agfa HealthCare NV · System, Image Processing, Radiological
  2 deaths2 reports
• GPS 531-25-00

  Exactech, Inc. · System, image processing, radiological
  2 reports
• GPS 531-01-03

  Exactech, Inc. · System, image processing, radiological
  2 reports
• Change Healthcare Enterprise Viewer 2.1

  Change Healthcare Canada Company · System, Image Processing, Radiological
  2 reports
• AccuPlan System ZB-KT001

  Medcad · System, Image Processing, Radiological
  1 report
• VSP System Maxilla Marking Guide

  3d Systems, Inc. · System, Image Processing, Radiological
  1 report
• Merge PACS 7.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 report
• Merge PACS 6.6.3.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 report
• Merge PACS 8.2

  Merge Healthcare Solutions Inc. · System, Image Processing, Radiological
  1 report
• Cerner SkyVue® SkyVue4

  Cerner Corporation · System, Image Processing, Radiological
  1 report
• DynaCAD 3.5

  Icad, Inc. · System, Image Processing, Radiological
  1 report
• Clarity ZMED-2XYAC-019

  Z Microsystems, Inc. · System, Image Processing, Radiological
  1 report
• IntelliSpace Cardiovascular IntelliSpace Cardiovascular 1.2

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 report
• IntelliSpace Cardiovascular 2.3

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 report
• Invivo 459801572611

  Philips DS North America LLC · System, image processing, radiological
  1 report
• IntelliSpace Portal IntelliSpace Portal - 12

  Philips Medical Systems Nederland B.V. · System, image processing, radiological
  1 report
• Affiniti 30 Ultrasound System 795218

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 report
• EPIQ 7 Diamond Select Ultrasound System 795117

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 report
• EPIQ 5 Ultrasound System 795204

  Philips Ultrasound LLC · System, Image Processing, Radiological
  1 report
• IntelliSpace Cardiovascular 9

  Philips Medical Systems Nederland B.V. · System, Image Processing, Radiological
  1 report
• ROSA® Shoulder 20-8087-400-00

  Orthosoft Inc · System, image processing, radiological
  1 report
• Arthrex® AR-5400-04

  Arthrex, Inc. · System, image processing, radiological
  1 report
• Arthrex® AR-5400-21

  Arthrex, Inc. · System, image processing, radiological
  1 report
• Elements Trajectory Planning 2.5

  Brainlab SE · System, Image Processing, Radiological
  1 report
• syngo.via 11461857

  Siemens Healthcare GmbH · System, image processing, radiological
  1 report
• CUPTIMIZE Advanced 4515-80-070

  Depuy (Ireland) · System, image processing, radiological
  1 report
• GPS 531-20-00

  Exactech, Inc. · System, image processing, radiological
  1 report
• Equinoxe 531-55-26

  Exactech, Inc. · System, Image Processing, Radiological
  1 report
• Equinoxe 531-55-64

  Exactech, Inc. · System, Image Processing, Radiological
  1 report
• MULTIVIEW

  Hologic, Inc. · System, image processing, radiological
  1 report
• McKesson Radiology 12.3

  Change Healthcare Canada Company · System, Image Processing, Radiological
  1 death1 report
• Change Healthcare Cardiology 15.0.1

  Change Healthcare Canada Company · System, Image Processing, Radiological
  1 report
• Vue PACS

  Carestream Health, Inc. · System, image processing, radiological
  1 death1 report
• Vue PACS

  Carestream Health, Inc. · System, image processing, radiological
  1 report
• HealthMyne QIDS 3.0

  Healthmyne, Inc. · System, Image Processing, Radiological
  1 report