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LLZ

System, Image Processing, Radiological

产品代码
LLZ
器械名称
System, Image Processing, Radiological
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 892.2050
FDA 专业组
Radiology
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
2286 件

该代码近三年的 510(k)（177 件）

数据窗口为最近三年。最新一件：2026-08-17。

510(k) 号批准日期申请人器械名称
K2615002026-08-17S.M.A.I.OKBA3D (v2.4.0) 摘要
K2624492026-08-14ADVAHEALTH SOLUTIONS, LLCAdvaView 摘要
K2619162026-08-12Cortechs Labs, Inc.NeuroQuant PET 摘要
K2609362026-07-31Neurocareai, Inc. (Dba Savelife.Ai)RadioViewAI 摘要
K2605882026-07-29Cleerly, Inc.Cleerly LABS 摘要
K2624622026-07-24Boston Scientific CorporationTheraSphere 360™ Y-90 Management Platform 摘要
K2621432026-07-23Candelis, Inc.ImageGrid StreamVue 摘要
K2605002026-07-21ResolutionMD, Inc.ResolutionMD 摘要
K2621202026-07-10Avara SoftwareAvara Viewer 摘要
K2538992026-07-09Provect.AI3D-Anywhere 摘要
K2614652026-07-06INDIGO TECHNOLOGIESINDIRA CLOUD VIEWER 摘要
K2605762026-06-30MeVis Medical Solutions AGMeVis AVM Contour 摘要
K2602312026-06-25Apryse Software CorpMiPACS V5 (1.0.0) 摘要
K2534212026-06-22Quantified Imaging LimitedPerfusion Measurement Platform v1 摘要
K2613522026-06-08One Ortho2D Hip Planning Software 摘要
K2601162026-06-03CustoMED , Ltd.CustoMED Viewer 摘要
K2542652026-05-27Videomed Srl ( a Baxter Healthcare CorHelion Viewer Suite 摘要
K2538312026-05-18Cercare Medical A/SCMN Capillary Function with Virtual Expert for MRI, 摘要
K2540132026-05-14Subtle Medical, Inc.SubtleHD-PET (1.x) 摘要
K2603212026-05-08Orthopedic Driven Imaging, LLCHipGuide (V 1.0.0.0) 摘要
K2607162026-05-04Cefla S.C.Neowise 摘要
K2600092026-04-24Broncus Medical, Inc.LungPoint Virtual Bronchoscopic Navigation (VBN) Sof 摘要
K2542372026-04-23CliniComp, Intl.CCI PACS VIEWER (PACS-US-001) 摘要
K2530292026-03-31Mediott, Inc.RW-1 摘要
K2539502026-03-30Avatar MedicalAvatar Medical Vision 摘要
K2521952026-03-27Artiness S.R.LARTICOR planner 摘要
K2604792026-03-13Boston Scientific CorporationTheraSphere 360™ Y-90 Management Platform 摘要
K2531112026-03-13Good Methods Global, Inc.Aeka Imaging 摘要
K2519642026-03-12Materialise NVMimics Thoracic Planner 摘要
K2534862026-02-23Skia, Inc.SKIA-Head (Model: SKIA-ST00) 摘要
K2602052026-02-19AS Software, LLCAS Software Version Asera 摘要
K2539272026-02-06Live Medica, LLCLiveMedica Enterprise PACS 摘要
K2515772026-02-06Augmented Reality Software S.L.LAIA XR 摘要
K2537842026-01-08Singular Health Pty, Ltd.3DICOM MD Cloud 摘要
K2536392026-01-08GE HealthcareView 摘要
K2530082026-01-05Maihub Corp.maiLink 摘要
K2518832025-12-11Mim Software, Inc.MIM – LesionID Pro 摘要
K2518802025-11-21Archy Dental, Inc.Archy Dental Imaging 摘要
K2534952025-11-20Siemens Healthineers AGsyngo.MR Applications (VB80) 摘要
K2514102025-11-04Vieworks Co., Ltd.VXvue 摘要
K2515322025-11-03Mighty Oak MedicalAcorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC 摘要
K2525472025-10-28Boston Scientific CorporationTheraSphere 360™ Y-90 Management Platform 摘要
K2510302025-10-22Sirona MedicalSirona Advanced Imaging Suite 摘要
K2524762025-10-16Brainlab AGViewer (5.4); Elements Viewer; Mixed Reality Viewer; 摘要
K2521992025-10-15Agfa Healthcare N.V.AGFA HealthCare Enterprise Imaging 摘要
K2513632025-10-08Elekta Solutions ABProKnow DS 摘要
K2500392025-10-03HealthhubHPACS 摘要
K2512152025-10-02Philips Medical Systems Nederland B.V.Philips IntelliSpace Cardiovascular 摘要
K2500452025-09-24Shanghai United Imaging Healthcare Co.uWS-Angio Pro 摘要
K2500402025-09-12Shanghai United Imaging Healthcare Co.uWS-Angio 摘要
K2423142025-09-11Augment Intelligent Medical System (ChMinimally Invasive Prostate Surgery Navigation Syste 摘要
K2526082025-09-09Siemens Healthcare GmbHAI-Rad Companion Prostate MR 摘要
K2511682025-09-04Carestream Health, Inc.Image Suite 摘要
K2502902025-08-29TwinsightSurgiTwin 摘要
K2525262025-08-26Ischemaview, Inc.Rapid DeltaFuse 摘要
K2436802025-08-25Olea Medical S.A.S.Neurovascular Insight V1.0 摘要
K2324562025-08-11Mediott, Inc.RW-1 摘要
K2506642025-08-07UC-CARE , Ltd.Navigo Workstation 2.3 (FPRMC00039) 摘要
K2510382025-08-06Shen Zhen Cambridge-Hit Co., Ltd.Digital Radiographic Imaging Acquisition Software - 摘要
K2440162025-08-05Claritas Healthtech Pte, Ltd.iPETcertum (v1.0) 摘要
K2436812025-07-23Olea Medical S.A.S.Neuro Insight V1.0 摘要
K2507162025-07-23Infomed Software, S.L.IMAGE ONE 摘要
K2506862025-07-22Neurospectrum Insights Corp.GyriCalc (Version 1.0.0) 摘要
K2501812025-07-15Philips Medical Systems Nederland B.V.AV Viewer 摘要
K2501202025-07-14Narnar, LLCGECHO 摘要
K2518632025-07-07Customsurg AGCustomSurg OrthoPlanner 摘要
K2436662025-06-17Shanghai United Imaging Healthcare Co.uOmniscan 摘要
K2440122025-06-16Navier MedicalMosaic (V1.0.1) 摘要
K2437032025-06-05DeepHealth, Inc.TechLive 摘要
K2508002025-06-05Philips DS North America, LLCUroNav 4 摘要
K2511092025-05-21Ray Co., Ltd.SMARTDent 摘要
K2436322025-05-12Shanghai United Imaging Healthcare Co.uWS-Angio Basic 摘要
K2430692025-05-02IntradysLUMYS (V1) 摘要
K2436972025-04-23Medacta International S.A.MySpine WebPlanner 摘要
K2436512025-04-21GE Medical Systems SCSVersaViewer 摘要
K2426472025-04-16Mysegmenter Technologies, Inc.MySegmenter (v2.0.0) 摘要
K2503012025-04-14Merge Healthcare IncorporatedMerge Universal Viewer (MUV) 摘要
K2425522025-04-08Icat Solutions, Ltd.Horos Mobile 摘要
K2432922025-03-20Avatar MedicalbrAIn™ Shoulder Positioning 摘要
K2421612025-03-18Radlink, Inc.Radlink GPS Pro Imaging 摘要
K2419752025-03-17Serv Medical Pte., Ltd.SERV MEDICAL CDSS 摘要
K2417652025-03-14Dosisoft SAPLANET Onco Dose (3.2) 摘要
K2415462025-02-26Fovia, Inc.aiCockpit AI Viewer 摘要
K2503482025-02-25JLK, Inc.JLK-AILink 摘要
K2428382025-02-21Aikenist Technologies Pvt, Ltd.QuickRad 摘要
K2422402025-02-20Caristo Diagnostics , Ltd.CaRi-Plaque 摘要
K2414252025-02-12Aspen Imaging Healthcare, Inc.AspenView 摘要
K2433332025-02-04Roclub GmbHrTOP 摘要
K2416942025-01-31Tae Young Soft Co., Ltd.ZeTTA PACS 摘要
K2418192025-01-23Cyncronus, LLCCephNinja 摘要
K2422052025-01-14Specto MedicalSpectoMed (v1.0) 摘要
K2418082025-01-07Corin U.S.A. LimitedApolloHipX (THR.SS.0001) 摘要
K2421232025-01-06Brainomix LimitedBrainomix 360 e-CTA 摘要
K2413502025-01-03Ge Medical Systems Israel, Functional Clarify DL 摘要
K2425992024-12-20Carlsmed, Inc.aprevo® Digital Planning 摘要
K2423622024-12-20Nexsys Electronics Inc. Dba MedwebLightning Viewer 摘要
K2419892024-12-06Cercare Medical A/SCercare Medical Neurosuite (CMN) Capillary Function 摘要
K2409262024-12-06Peek Health, S.A.PeekMed web 摘要
K2434472024-12-05Navbit Pty, Ltd.Rapid Surgical Plan (RSP-SW-001) 摘要
K2428102024-11-26Radunity Corp.RadUnity (Version 1.0.0) 摘要
K2414952024-11-21Jazz ImagingJazz Classic 摘要
K2423292024-11-18Philips Healthcare (Suzhou) Co., Ltd.CT Collaboration Live 摘要
K2420622024-11-15Mycardium AI Limited1CMR Pro 摘要
K2419812024-11-12Change Healthcare Canada CompanyChange Healthcare Stratus Imaging PACS 摘要
K2427092024-11-04JLK, Inc.JLK-PWI 摘要
K2412232024-10-31Erad, Inc.eRAD PACS 摘要
K2425122024-10-24Philips Medical Systems Nederland B.V.ROCC Console 摘要
K2430122024-10-23Mim Software, Inc.MIM – Symphony HDR Fusion 摘要
K2432092024-10-22Nordicneurolab ASnordicMEDiVA 摘要
K2425562024-10-16JLK, Inc.JLK-CTP 摘要
K2403852024-10-15Mediimg CorporationVINT 摘要
K2415692024-10-11Siemens Medical Solutions USA, Inc.syngo Application Software 摘要
K2402432024-09-23DRTECH CorporationEConsole2 摘要
K2415242024-09-12Elucid Bioimaging, Inc.Elucid PlaqueIQ 摘要
K2339982024-09-05Aiq Global, Inc.TRAQinform IQ 摘要
K2413022024-08-23Samsung Medison Co., Ltd.SonoSync 摘要
K2402902024-08-21Subtle Medical, Inc.AiMIFY (1.x) 摘要
K2410942024-08-13Turing Medical Technologies, Inc.Bullsai 摘要
K2407242024-08-08Synthesis Health Intelligence, Inc.SynthVISION 1.0.0 摘要
K2337612024-08-05Longwood Valley Medical , Ltd.Orthopaedic Surgery Planning Software (AIJOINT) 摘要

另有 57 件未列出。

FDA 官方分类页： LLZ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。