Product code LLZ
Current FDA Classification
- Device name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026-01-08 |
| K253639 | View | GE Healthcare | 2026-01-08 |
| K253008 | maiLink | Maihub Corp. | 2026-01-05 |
| K251883 | MIM LesionID Pro | Mim Software, Inc. | 2025-12-11 |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 2025-11-21 |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | 2025-11-20 |
| K251410 | VXvue | Vieworks Co., Ltd. | 2025-11-04 |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | 2025-11-03 |
| K252547 | TheraSphere 360 Y-90 Management Platform | Boston Scientific Corporation | 2025-10-28 |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 2025-10-22 |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | 2025-10-16 |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025-10-15 |
| K251363 | ProKnow DS | Elekta Solutions AB | 2025-10-08 |
| K250039 | HPACS | Healthhub | 2025-10-03 |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025-10-02 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10603295562108 | VELYS Hip Navigation | DEPUY ORTHOPAEDICS, INC. | 2026-03-24 |
| 08809985659300 | R2GATE Windows | Megagen Implant Co. Ltd | 2026-03-24 |
| 05404028000861 | Mimics Thoracic Planner | Materialise NV | 2026-03-20 |
| 17540262140255 | Change Healthcare Stratus Imaging Viewer | Change Healthcare Canada Company | 2026-03-19 |
| 08800018412008 | EConsole2 | DRTECH Corporation | 2026-03-17 |
| 75401622502288 | Synthesis Vision Viewer | Synthesis Health Intelligence Inc | 2026-03-17 |
| 00860010575314 | AS Software | As Software, LLC | 2026-03-10 |
| 00860010575321 | AS Software | As Software, LLC | 2026-03-10 |
| 04719878870009 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 04719878870108 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 04719878870122 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 04719878870191 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 04719878870276 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 04719878870290 | EBM | EBM TECHNOLOGIES INCORPORATED | 2026-03-10 |
| 09358140000079 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (o8t) | 2026-03-09 |
| 17540262090154 | Change Healthcare Cardiology | Change Healthcare Canada Company | 2026-03-09 |
| 06971576834334 | uWS | Shanghai United Imaging Healthcare Co., Ltd. | 2026-03-08 |
| 06971576834341 | uWS | Shanghai United Imaging Healthcare Co., Ltd. | 2026-03-08 |
| 07350092810678 | Sectra Orthopedic Package | Sectra AB | 2026-03-05 |
| 00198953059173 | ViewPoint | GE Healthcare GmbH | 2026-02-27 |
| 00850025268400 | Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 2026-02-27 |
| 08800169200134 | ON3D | 3D ONS, INC. | 2026-02-19 |
| B403IQS11004 | iQ-SYSTEM PACS | IMAGE Information Systems Europe GmbH | 2026-02-19 |
| 00817886020677 | Joints | MEDSTRAT, INC. | 2026-02-16 |
| 00860015443526 | CARPL | Carpl.AI, Inc. | 2026-02-16 |
| 00862234000320 | vRad Viewer | vRad | 2026-02-13 |
| 04260489720202 | mediCAD® Web | mediCAD Hectec GmbH | 2026-02-11 |
| 75401622502271 | Synthesis Vision Viewer | Synthesis Health Intelligence Inc | 2026-02-10 |
| 10885862518767 | EXACTECHGPS | Exactech, Inc. | 2017-12-18 |
| B131ZIOE1001SYS0 | Ziostation | QI IMAGING LLC | 2017-02-12 |