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 2,293 510(k) submissions under this product code.
Devices under product code LLZ share 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.
At a glance
Ask AI- Cleared devices
- 2,293
- Device class
- Class 2
- Regulation
- 892.2050
- Latest clearance
Cleared devices under product code LLZ
Ask AIShowing the 50 most recent of 2,293 cleared devices. Clearances from 2025-10-22 to 2026-09-29.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | |
| K262442 | HipStudio Analysis | Replasia BV | |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | |
| K260588 | Cleerly LABS | Cleerly, Inc. | |
| 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 |
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