LLZ
2,283 FDA 510(k) clearances · Product code
77 daysmedian time to decision
239 days90th percentile
2,000clearances measured
FDA profile
- Official device name
- System, Image Processing, Radiological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 70 · 2022: 28 · 2023: 26 · 2024: 42 · 2025: 118 · 2026: 313
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
| CustoMED Viewer (K260116) | CustoMED , Ltd. | 2026-06-03 |
| Helion Viewer Suite (K254265) | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (K253831) | Cercare Medical A/S | 2026-05-18 |
| SubtleHD-PET (1.x) (K254013) | Subtle Medical, Inc. | 2026-05-14 |
| HipGuide (V 1.0.0.0) (K260321) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| Neowise (K260716) | Cefla S.C. | 2026-05-04 |
| LungPoint Virtual Bronchoscopic Navigation (VBN) Software (K260009) | Broncus Medical, Inc. | 2026-04-24 |
| CCI PACS VIEWER (PACS-US-001) (K254237) | CliniComp, Intl. | 2026-04-23 |
| RW-1 (K253029) | Mediott, Inc. | 2026-03-31 |
| Avatar Medical Vision (K253950) | Avatar Medical | 2026-03-30 |
| ARTICOR planner (K252195) | Artiness S.R.L | 2026-03-27 |
| Aeka Imaging (K253111) | Good Methods Global, Inc. | 2026-03-13 |
| TheraSphere 360™ Y-90 Management Platform (K260479) | Boston Scientific Corporation | 2026-03-13 |
| Mimics Thoracic Planner (K251964) | Materialise NV | 2026-03-12 |
| SKIA-Head (Model: SKIA-ST00) (K253486) | Skia, Inc. | 2026-02-23 |
| AS Software Version Asera (K260205) | AS Software, LLC | 2026-02-19 |
| LAIA XR (K251577) | Augmented Reality Software S.L. | 2026-02-06 |
| LiveMedica Enterprise PACS (K253927) | Live Medica, LLC | 2026-02-06 |
| View (K253639) | GE Healthcare | 2026-01-08 |
| 3DICOM MD Cloud (K253784) | Singular Health Pty, Ltd. | 2026-01-08 |
| maiLink (K253008) | Maihub Corp. | 2026-01-05 |
| MIM – LesionID Pro (K251883) | Mim Software, Inc. | 2025-12-11 |
| Archy Dental Imaging (K251880) | Archy Dental, Inc. | 2025-11-21 |
| syngo.MR Applications (VB80) (K253495) | Siemens Healthineers AG | 2025-11-20 |
| VXvue (K251410) | Vieworks Co., Ltd. | 2025-11-04 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K251532) | Mighty Oak Medical | 2025-11-03 |
| TheraSphere 360™ Y-90 Management Platform (K252547) | Boston Scientific Corporation | 2025-10-28 |
| Sirona Advanced Imaging Suite (K251030) | Sirona Medical | 2025-10-22 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K252476) | Brainlab AG | 2025-10-16 |
| AGFA HealthCare Enterprise Imaging (K252199) | Agfa Healthcare N.V. | 2025-10-15 |
| ProKnow DS (K251363) | Elekta Solutions AB | 2025-10-08 |
| HPACS (K250039) | Healthhub | 2025-10-03 |
| Philips IntelliSpace Cardiovascular (K251215) | Philips Medical Systems Nederland B.V. | 2025-10-02 |
| uWS-Angio Pro (K250045) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 |
| uWS-Angio (K250040) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 |
| Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) (K242314) | Augment Intelligent Medical System (China) Co., Ltd. | 2025-09-11 |
| AI-Rad Companion Prostate MR (K252608) | Siemens Healthcare GmbH | 2025-09-09 |
| Image Suite (K251168) | Carestream Health, Inc. | 2025-09-04 |
| SurgiTwin (K250290) | Twinsight | 2025-08-29 |
| Rapid DeltaFuse (K252526) | Ischemaview, Inc. | 2025-08-26 |
| Neurovascular Insight V1.0 (K243680) | Olea Medical S.A.S. | 2025-08-25 |
| RW-1 (K232456) | Mediott, Inc. | 2025-08-11 |
| Navigo Workstation 2.3 (FPRMC00039) (K250664) | UC-CARE , Ltd. | 2025-08-07 |
| Digital Radiographic Imaging Acquisition Software - DR (RiasDR) (K251038) | Shen Zhen Cambridge-Hit Co., Ltd. | 2025-08-06 |
| iPETcertum (v1.0) (K244016) | Claritas Healthtech Pte, Ltd. | 2025-08-05 |
| IMAGE ONE (K250716) | Infomed Software, S.L. | 2025-07-23 |
| Neuro Insight V1.0 (K243681) | Olea Medical S.A.S. | 2025-07-23 |
| GyriCalc (Version 1.0.0) (K250686) | Neurospectrum Insights Corp. | 2025-07-22 |
| AV Viewer (K250181) | Philips Medical Systems Nederland B.V. | 2025-07-15 |
| GECHO (K250120) | Narnar, LLC | 2025-07-14 |
| CustomSurg OrthoPlanner (K251863) | Customsurg AG | 2025-07-07 |
| uOmniscan (K243666) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 |
| Mosaic (V1.0.1) (K244012) | Navier Medical | 2025-06-16 |
| TechLive (K243703) | DeepHealth, Inc. | 2025-06-05 |
| UroNav 4 (K250800) | Philips DS North America, LLC | 2025-06-05 |
| SMARTDent (K251109) | Ray Co., Ltd. | 2025-05-21 |
| uWS-Angio Basic (K243632) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 |
| LUMYS (V1) (K243069) | Intradys | 2025-05-02 |
| MySpine WebPlanner (K243697) | Medacta International S.A. | 2025-04-23 |
| VersaViewer (K243651) | GE Medical Systems SCS | 2025-04-21 |
| MySegmenter (v2.0.0) (K242647) | Mysegmenter Technologies, Inc. | 2025-04-16 |
| Merge Universal Viewer (MUV) (K250301) | Merge Healthcare Incorporated | 2025-04-14 |
| Horos Mobile (K242552) | Icat Solutions, Ltd. | 2025-04-08 |
| brAIn™ Shoulder Positioning (K243292) | Avatar Medical | 2025-03-20 |
| Radlink GPS Pro Imaging (K242161) | Radlink, Inc. | 2025-03-18 |
| SERV MEDICAL CDSS (K241975) | Serv Medical Pte., Ltd. | 2025-03-17 |
| PLANET Onco Dose (3.2) (K241765) | Dosisoft SA | 2025-03-14 |
| aiCockpit AI Viewer (K241546) | Fovia, Inc. | 2025-02-26 |
| JLK-AILink (K250348) | JLK, Inc. | 2025-02-25 |
| QuickRad (K242838) | Aikenist Technologies Pvt, Ltd. | 2025-02-21 |
| CaRi-Plaque (K242240) | Caristo Diagnostics , Ltd. | 2025-02-20 |
| AspenView (K241425) | Aspen Imaging Healthcare, Inc. | 2025-02-12 |
| rTOP (K243333) | Roclub GmbH | 2025-02-04 |
| ZeTTA PACS (K241694) | Tae Young Soft Co., Ltd. | 2025-01-31 |
| CephNinja (K241819) | Cyncronus, LLC | 2025-01-23 |
| SpectoMed (v1.0) (K242205) | Specto Medical | 2025-01-14 |
| ApolloHipX (THR.SS.0001) (K241808) | Corin U.S.A. Limited | 2025-01-07 |
| Brainomix 360 e-CTA (K242123) | Brainomix Limited | 2025-01-06 |
| Clarify DL (K241350) | Ge Medical Systems Israel, Functional Imaging | 2025-01-03 |
| aprevo® Digital Planning (K242599) | Carlsmed, Inc. | 2024-12-20 |
| Lightning Viewer (K242362) | Nexsys Electronics Inc. Dba Medweb | 2024-12-20 |
| Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (K241989) | Cercare Medical A/S | 2024-12-06 |
| PeekMed web (K240926) | Peek Health, S.A. | 2024-12-06 |
| Rapid Surgical Plan (RSP-SW-001) (K243447) | Navbit Pty, Ltd. | 2024-12-05 |
| RadUnity (Version 1.0.0) (K242810) | Radunity Corp. | 2024-11-26 |
| Jazz Classic (K241495) | Jazz Imaging | 2024-11-21 |
| CT Collaboration Live (K242329) | Philips Healthcare (Suzhou) Co., Ltd. | 2024-11-18 |
| 1CMR Pro (K242062) | Mycardium AI Limited | 2024-11-15 |
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Every clearance here is in the API, with alerts when new ones post.