FDA Product Code
FDA Product Code LLZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.2050
510(k) Clearances — 2,293 records · page 2 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241350 | Clarify DL | Ge Medical Systems Israel, Functional Imaging | 2025-01-03 | Traditional | PDF ↗ |
| K242362 | Lightning Viewer | Nexsys Electronics Inc. Dba Medweb | 2024-12-20 | Traditional | PDF ↗ |
| K242599 | aprevo® Digital Planning | Carlsmed, Inc. | 2024-12-20 | Traditional | PDF ↗ |
| K241989 | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert | Cercare Medical A/S | 2024-12-06 | Traditional | PDF ↗ |
| K240926 | PeekMed web | Peek Health, S.A. | 2024-12-06 | Traditional | PDF ↗ |
| K243447 | Rapid Surgical Plan (RSP-SW-001) | Navbit Pty, Ltd. | 2024-12-05 | Traditional | PDF ↗ |
| K242810 | RadUnity (Version 1.0.0) | Radunity Corp. | 2024-11-26 | Traditional | PDF ↗ |
| K241495 | Jazz Classic | Jazz Imaging | 2024-11-21 | Traditional | PDF ↗ |
| K242329 | CT Collaboration Live | Philips Healthcare (Suzhou) Co., Ltd. | 2024-11-18 | Traditional | PDF ↗ |
| K242062 | 1CMR Pro | Mycardium AI Limited | 2024-11-15 | Abbreviated | PDF ↗ |
| K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | 2024-11-12 | Traditional | PDF ↗ |
| K242709 | JLK-PWI | JLK, Inc. | 2024-11-04 | Traditional | PDF ↗ |
| K241223 | eRAD PACS | Erad, Inc. | 2024-10-31 | Traditional | PDF ↗ |
| K242512 | ROCC Console | Philips Medical Systems Nederland B.V. | 2024-10-24 | Traditional | PDF ↗ |
| K243012 | MIM Symphony HDR Fusion | Mim Software, Inc. | 2024-10-23 | Special | PDF ↗ |
| K243209 | nordicMEDiVA | Nordicneurolab AS | 2024-10-22 | Traditional | PDF ↗ |
| K242556 | JLK-CTP | JLK, Inc. | 2024-10-16 | Traditional | PDF ↗ |
| K240385 | VINT | Mediimg Corporation | 2024-10-15 | Traditional | PDF ↗ |
| K241569 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2024-10-11 | Traditional | PDF ↗ |
| K240243 | EConsole2 | DRTECH Corporation | 2024-09-23 | Traditional | PDF ↗ |
| K241524 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2024-09-12 | Traditional | PDF ↗ |
| K233998 | TRAQinform IQ | Aiq Global, Inc. | 2024-09-05 | Traditional | PDF ↗ |
| K241302 | SonoSync | Samsung Medison Co., Ltd. | 2024-08-23 | Traditional | PDF ↗ |
| K240290 | AiMIFY (1.x) | Subtle Medical, Inc. | 2024-08-21 | Traditional | PDF ↗ |
| K241094 | Bullsai | Turing Medical Technologies, Inc. | 2024-08-13 | Traditional | PDF ↗ |
| K240724 | SynthVISION 1.0.0 | Synthesis Health Intelligence, Inc. | 2024-08-08 | Traditional | PDF ↗ |
| K233761 | Orthopaedic Surgery Planning Software (AIJOINT) | Longwood Valley Medical , Ltd. | 2024-08-05 | Traditional | PDF ↗ |
| K241114 | EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) | Ewoosoft Co., Ltd. | 2024-07-23 | Special | PDF ↗ |
| K241879 | vRad Viewer | Virtual Radiologic Corporation | 2024-07-18 | Special | PDF ↗ |
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation | 2024-07-17 | Traditional | PDF ↗ |
| K241121 | MICSI-RMT | Microstructure Imaging, Inc. | 2024-07-17 | Traditional | PDF ↗ |
| K241300 | ViewPoint 6 | Ge Healthcare GmbH | 2024-07-02 | Traditional | PDF ↗ |
| K233908 | cNeuro cDAT | Combinostics OY | 2024-07-01 | Traditional | PDF ↗ |
| K241608 | nordicMEDiVA | Nordicneurolab AS | 2024-06-28 | Traditional | PDF ↗ |
| K233331 | MediOMx | Pmx, Inc. | 2024-06-17 | Traditional | PDF ↗ |
| K240281 | Bone Suppression Software | Konica Minolta, Inc. | 2024-05-31 | Traditional | PDF ↗ |
| K223427 | Mimics Enlight CMF | Materialise NV | 2024-05-31 | Traditional | PDF ↗ |
| K240294 | Syngo Carbon Enterprise Access (VA40A) | Siemens Healthcare GmbH | 2024-05-23 | Traditional | PDF ↗ |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | 2024-05-21 | Traditional | PDF ↗ |
| K233620 | MIM - Centiloid Scaling | Mim Software, Inc. | 2024-05-20 | Traditional | PDF ↗ |
| K232862 | MIM Monte Carlo Dosimetry | Mim Software, Inc. | 2024-05-13 | Traditional | PDF ↗ |
| K232976 | VUZE System | Vuze Medical , Ltd. | 2024-05-09 | Traditional | PDF ↗ |
| K232514 | MIM Dose Analysis | Mim Software, Inc. | 2024-05-06 | Traditional | PDF ↗ |
| K233699 | SubtleREFORMAT (1.x) | Subtle Medical, Inc. | 2024-04-29 | Traditional | PDF ↗ |
| K240822 | Image Management V15 | Philips Medical Systems Technologies | 2024-04-24 | Traditional | PDF ↗ |
| K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | 2024-04-24 | Traditional | PDF ↗ |
| K233582 | Rapid | Ischemaview, Inc. | 2024-04-22 | Traditional | PDF ↗ |
| K232641 | Neorad Pacs (Neorad Pacs) | Everrtech Software Pvt, Ltd. | 2024-04-10 | Traditional | PDF ↗ |
| K232891 | CARPL (CARPL) | Carpl Ai, Inc. | 2024-03-27 | Traditional | PDF ↗ |
| K240620 | Cube Navigator | Medical Templates AG | 2024-03-25 | Traditional | PDF ↗ |
| K233660 | nCommand Lite System | Ionic Health | 2024-03-18 | Traditional | PDF ↗ |
| K233599 | X-Clever (ASHK100G) | Lg Electronics.Inc | 2024-03-18 | Traditional | PDF ↗ |
| K233930 | MRCP+ version 2 (MRCP+ v2) | Perspectum | 2024-03-13 | Traditional | PDF ↗ |
| K233572 | Autofuse | Pymedix | 2024-03-06 | Traditional | PDF ↗ |
| K233217 | Mimics Cardiac Planner | Materialise NV | 2024-02-12 | Traditional | PDF ↗ |
| K231662 | Aid-U | Iaid | 2024-02-08 | Traditional | PDF ↗ |
| K232007 | CAAS MR Solutions | Pie Medical Imaging BV | 2024-02-01 | Traditional | PDF ↗ |
| K232339 | Augmented Reality Application | Sira Medical, Inc. | 2024-02-01 | Traditional | PDF ↗ |
| K231396 | CEPHX- Cephalometric Analysis Software | Orca Dental AI , Ltd. | 2024-01-31 | Traditional | PDF ↗ |
| K233714 | BreView | GE Medical Systems SCS | 2024-01-25 | Traditional | PDF ↗ |
| K231607 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2024-01-24 | Special | PDF ↗ |
| K233226 | FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC | 2024-01-17 | Traditional | PDF ↗ |
| K232589 | Horos MD | Icat Solutions, Ltd. | 2024-01-03 | Traditional | PDF ↗ |
| K232744 | syngo Virtual Cockpit (VB10A) | Siemens Healthcare GmbH | 2023-12-21 | Traditional | PDF ↗ |
| K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2023-12-20 | Traditional | PDF ↗ |
| K233176 | uOmnispace.MI | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K231570 | StrokeViewer Perfusion | Nico-Lab B.V. | 2023-12-14 | Traditional | PDF ↗ |
| K233634 | TeleScan | Bb Imaging | 2023-12-12 | Traditional | PDF ↗ |
| K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023-12-08 | Traditional | PDF ↗ |
| K232661 | Myocardial Strain Software Application | Circle Cardiovascular Imaging | 2023-12-07 | Traditional | PDF ↗ |
| K231498 | TraumaCad Neo | Brainlab , Ltd. | 2023-11-20 | Traditional | PDF ↗ |
| K230856 | BrainSpec Core Software | Brainspec, Inc. | 2023-11-14 | Traditional | PDF ↗ |
| K230854 | SwiftMR | Airs Medical, Inc. | 2023-10-27 | Traditional | PDF ↗ |
| K232086 | spineEOS | Eos Imaging | 2023-10-24 | Traditional | PDF ↗ |
| K223909 | R2GATE Lite TM | Megagen Implant Co., Ltd. | 2023-10-20 | Traditional | PDF ↗ |
| K231225 | EConsole1 | DRTECH Corporation | 2023-10-18 | Traditional | PDF ↗ |
| K230249 | Ikshana | Immersivetouch | 2023-10-16 | Traditional | PDF ↗ |
| K231642 | Veuron-Brain-pAb3 | Heuron Co., Ltd. | 2023-10-13 | Traditional | PDF ↗ |
| K230252 | OFIX MIS App | Orthofix US, LLC | 2023-09-26 | Traditional | PDF ↗ |
| K223659 | Jazz | Ai Medical AG | 2023-09-22 | Traditional | PDF ↗ |
| K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | 2023-09-20 | Traditional | PDF ↗ |
| K220034 | NEUROShield | In-Med Prognostics L3c | 2023-09-14 | Traditional | PDF ↗ |
| K231353 | AccuCTP Pro | ArteryFlow Technology Co., Ltd. | 2023-09-14 | Special | PDF ↗ |
| K232189 | OrionXR | Hoth Intelligence, Inc. | 2023-09-14 | Traditional | PDF ↗ |
| K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | 2023-09-01 | Traditional | PDF ↗ |
| K231656 | Brainomix 360 e-MRI | Brainomix Limited | 2023-08-30 | Traditional | PDF ↗ |
| K223180 | AIRAscore | Airamed GmbH | 2023-08-25 | Traditional | PDF ↗ |
| K231503 | CUPTIMIZE Advanced | DePuy Orthopaedics, Inc. | 2023-08-22 | Traditional | PDF ↗ |
| K223660 | SaintView | Inviz Corporation | 2023-08-14 | Traditional | PDF ↗ |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 | Special | PDF ↗ |
| K230540 | Patient Specific Planning Solution 3D Bone Models | Biomet Manufacturing Corp | 2023-07-25 | Traditional | PDF ↗ |
| K223322 | Argus Cognitive ReVISION Software | Argus Cognitive, Inc. | 2023-07-24 | Traditional | PDF ↗ |
| K222683 | Fibroid Mapping Reviewer Application (FMRA) | Nesa Medtech Private Limited | 2023-07-17 | Traditional | PDF ↗ |
| K230016 | Cercare Medical Neurosuite | Cercare Medical A/S | 2023-07-14 | Traditional | PDF ↗ |
| K231041 | JiveX (Model Number / Release: 5.4) | Visus Health IT GmbH | 2023-07-14 | Traditional | PDF ↗ |
| K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | Sentiar, Inc. | 2023-07-14 | Traditional | PDF ↗ |
| K231351 | Chondral Quant | Siemens Medical Soultions USA, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K223125 | XR90 (XR90-SYS) | Mediview Xr, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K213253 | Pixyl.Neuro | Pixyl SA | 2023-06-30 | Traditional | PDF ↗ |
| K223048 | Medisystem Pacs | Medilab Manutencao E Sitemas Ltda | 2023-06-23 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.