Product code LLZ
- 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
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| 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 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 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 |
| K251577 | LAIA XR | Augmented Reality Software S.L. | 2026-02-06 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |
| K253639 | View | GE Healthcare | 2026-01-08 |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00866463000496 | STAGE | Spintech, Inc. | 2026-07-23 |
| 00854810007229 | iCRco Clarity Viewer | IcRco, Inc. | 2026-07-22 |
| 17540262200102 | Change Healthcare Stratus Imaging Diagnostic Viewer | Change Healthcare Canada Company | 2026-07-22 |
| 17540262090161 | Change Healthcare Cardiology | Change Healthcare Canada Company | 2026-07-21 |
| M722CP26183V261830 | ClearRead CT Platform Docker | Riverain Technologies, Inc. | 2026-07-17 |
| 00854393006084 | Velocity | VARIAN MEDICAL SYSTEMS, INC. | 2026-07-16 |
| G874AVARAVIEWER0010 | Avara Viewer | AVARA SOFTWARE LLC | 2026-07-13 |
| 06938396401603 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396410124 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401719 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401702 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401658 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401634 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401597 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401566 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401559 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 06938396401528 | SIUI | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-07-10 |
| 04260483290305 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-07-09 |
| G775EVOLVE4140 | EVOLVE | Smaart Medical Systems, Inc. | 2026-07-09 |
| 00860012615308 | Denti.AI Auto-Chart | Denti.AI Technology Inc | 2026-06-24 |
| 00860012615315 | Denti.AI Detect | Denti.AI Technology Inc | 2026-06-24 |
| 05060737370000 | CaRi-Plaque | CARISTO DIAGNOSTICS LIMITED | 2026-01-05 |
| 00850059977378 | TIMS System | FORESIGHT IMAGING, LLC | 2025-05-30 |
| 00850059977385 | TIMS System | FORESIGHT IMAGING, LLC | 2025-05-30 |
| 00850059977392 | TIMS System | FORESIGHT IMAGING, LLC | 2025-05-30 |
| 00850059977408 | TIMS System | FORESIGHT IMAGING, LLC | 2025-05-30 |
| 00866463000465 | STAGE | Spintech, Inc. | 2025-03-27 |
| B228INTELEHEART0 | InteleHeart | Les Systèmes Médicaux Intelerad Incorporée | 2024-05-16 |
| 07649990819006 | OsiriX MD | Pixmeo Sàrl | 2022-02-19 |
| 00842000101024 | Merge Universal Viewer | MERGE HEALTHCARE SOLUTIONS INC. | 2021-09-21 |