System, Image Processing, Radiological 510(k) Clearances
Product code LLZ is the FDA classification for System, Image Processing, Radiological, a Class 2 device regulated under 21 CFR 892.2050, reviewed by the FDA Radiology panel. FDA has cleared 2,281 510(k) submissions under this product code.
Devices under product code LLZshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.
- Cleared devices
- 2,281
- Device class
- Class 2
- Regulation
- 892.2050
- Latest clearance
Cleared devices under product code LLZ
Showing the 50 most recent of 2,281 cleared devices. Clearances from 2025-08-26 to 2026-07-24.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262462 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | |
| K262143 | ImageGrid StreamVue | Candelis, Inc. | |
| K260500 | ResolutionMD | ResolutionMD, Inc. | |
| K262120 | Avara Viewer | Avara Software | |
| K253899 | 3D-Anywhere | Provect.AI | |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | |
| K261352 | 2D Hip Planning Software | One Ortho | |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | |
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | |
| K260716 | Neowise | Cefla S.C. | |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | |
| K253029 | RW-1 | Mediott, Inc. | |
| K253950 | Avatar Medical Vision | Avatar Medical | |
| K252195 | ARTICOR planner | Artiness S.R.L | |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | |
| K251964 | Mimics Thoracic Planner | Materialise NV | |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | |
| K260205 | AS Software Version Asera | AS Software, LLC | |
| K251577 | LAIA XR | Augmented Reality Software S.L. | |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | |
| K253639 | View | GE Healthcare | |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | |
| K253008 | maiLink | Maihub Corp. | |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | |
| K253495 | syngo.MR Applications (VB80) | Siemens Healthineers AG | |
| K251410 | VXvue | Vieworks Co., Ltd. | |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical | |
| K252547 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | |
| K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | |
| K251363 | ProKnow DS | Elekta Solutions AB | |
| K250039 | HPACS | Healthhub | |
| K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | |
| K250045 | uWS-Angio Pro | Shanghai United Imaging Healthcare Co., Ltd. | |
| K250040 | uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. | |
| K242314 | Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. | |
| K252608 | AI-Rad Companion Prostate MR | Siemens Healthcare GmbH | |
| K251168 | Image Suite | Carestream Health, Inc. | |
| K250290 | SurgiTwin | Twinsight | |
| K252526 | Rapid DeltaFuse | Ischemaview, Inc. |
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