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 |
|---|---|---|---|
| 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 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00628184004500 | Intellijoint VIEW | Intellijoint Surgical Inc | 2026-06-09 |
| 00860005144082 | Brain Age | Deephealth, Inc. | 2026-06-08 |
| 07649997938038 | Swissmeda Dental Planning System | Swissmeda AG | 2026-06-08 |
| 07649997938052 | Swissmeda Dental Planning System | Swissmeda AG | 2026-06-08 |
| 08437021468212 | QP-Prostate | QUIBIM SOCIEDAD LIMITADA. | 2026-06-05 |
| 00850631008865 | Roentgen Works | Brit Systems, LLC | 2026-06-05 |
| 00850025268417 | Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 2026-06-05 |
| B359OAIIV2026051 | Ramsoft | Ramsoft Inc | 2026-06-04 |
| M722CD26127V260970 | ClearRead CT Docker | Riverain Technologies, Inc. | 2026-05-28 |
| 75401622522101 | Synthesis Vision Viewer | Synthesis Health Intelligence Inc | 2026-05-27 |
| 17540262200096 | Change Healthcare Stratus Imaging Diagnostic Viewer | Change Healthcare Canada Company | 2026-05-27 |
| EOLENEUROINSIGHTV1P00 | Neuro Insight | Olea Medical USA | 2026-04-13 |
| 09421904268333 | Volpara Scorecard | LUNIT INTERNATIONAL LIMITED | 2025-05-06 |
| 08800086200408 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | 2024-02-29 |
| 08800086200064 | Veuron-Brain-pAb2 | Heuron Co., Ltd. | 2022-02-18 |
| 08800086200026 | Veuron-Brain-pAb | Heuron Co., Ltd. | 2021-11-09 |
| 09421904268241 | VolparaDensity | LUNIT INTERNATIONAL LIMITED | 2020-10-01 |
| 09421904268319 | Volpara Density Map | LUNIT INTERNATIONAL LIMITED | 2020-09-24 |
| 09421904268289 | Volpara Density Map | LUNIT INTERNATIONAL LIMITED | 2020-09-24 |
| 09421904268258 | VolparaDensity | LUNIT INTERNATIONAL LIMITED | 2020-08-26 |
| 09421904268166 | VolparaDensity | LUNIT INTERNATIONAL LIMITED | 2018-12-18 |
| 04987670102493 | Vitrea Software Toshiba Package | CANON INC. | 2018-03-02 |
| 09421904268128 | Volpara Density Map | LUNIT INTERNATIONAL LIMITED | 2017-08-16 |
| 09421904268098 | VolparaDensity | LUNIT INTERNATIONAL LIMITED | 2017-08-16 |
| 00628914000017 | eUnity | Mach7 Technologies Canada Inc | 2017-07-28 |
| 00863686000302 | Breast Volume Navigator (BVN) | Metritrack, Inc. | 2017-05-01 |
| D848CURVEHERO0 | Curve Hero™ | Curve Dental | 2017-04-10 |
| D848CURVEIMAGE0 | Curve Image™ | Curve Dental | 2017-04-10 |
| 09421904268050 | Volpara Density Map | LUNIT INTERNATIONAL LIMITED | 2016-04-22 |
| 09421904268029 | VolparaDensity | LUNIT INTERNATIONAL LIMITED | 2016-04-22 |