LLZ
2,283 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Change Healthcare Stratus Imaging PACS (K241981) | Change Healthcare Canada Company | 2024-11-12 |
| JLK-PWI (K242709) | JLK, Inc. | 2024-11-04 |
| eRAD PACS (K241223) | Erad, Inc. | 2024-10-31 |
| ROCC Console (K242512) | Philips Medical Systems Nederland B.V. | 2024-10-24 |
| MIM – Symphony HDR Fusion (K243012) | Mim Software, Inc. | 2024-10-23 |
| nordicMEDiVA (K243209) | Nordicneurolab AS | 2024-10-22 |
| JLK-CTP (K242556) | JLK, Inc. | 2024-10-16 |
| VINT (K240385) | Mediimg Corporation | 2024-10-15 |
| syngo Application Software (K241569) | Siemens Medical Solutions USA, Inc. | 2024-10-11 |
| EConsole2 (K240243) | DRTECH Corporation | 2024-09-23 |
| Elucid PlaqueIQ (K241524) | Elucid Bioimaging, Inc. | 2024-09-12 |
| TRAQinform IQ (K233998) | Aiq Global, Inc. | 2024-09-05 |
| SonoSync (K241302) | Samsung Medison Co., Ltd. | 2024-08-23 |
| AiMIFY (1.x) (K240290) | Subtle Medical, Inc. | 2024-08-21 |
| Bullsai (K241094) | Turing Medical Technologies, Inc. | 2024-08-13 |
| SynthVISION 1.0.0 (K240724) | Synthesis Health Intelligence, Inc. | 2024-08-08 |
| Orthopaedic Surgery Planning Software (AIJOINT) (K233761) | Longwood Valley Medical , Ltd. | 2024-08-05 |
| EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) (K241114) | Ewoosoft Co., Ltd. | 2024-07-23 |
| vRad Viewer (K241879) | Virtual Radiologic Corporation | 2024-07-18 |
| Vitrea Software Package, VSTP-002A V2.0 (K240705) | Canon Medical Systems Corporation | 2024-07-17 |
| MICSI-RMT (K241121) | Microstructure Imaging, Inc. | 2024-07-17 |
| ViewPoint 6 (K241300) | Ge Healthcare GmbH | 2024-07-02 |
| cNeuro cDAT (K233908) | Combinostics OY | 2024-07-01 |
| nordicMEDiVA (K241608) | Nordicneurolab AS | 2024-06-28 |
| MediOMx (K233331) | Pmx, Inc. | 2024-06-17 |
| Bone Suppression Software (K240281) | Konica Minolta, Inc. | 2024-05-31 |
| Mimics Enlight CMF (K223427) | Materialise NV | 2024-05-31 |
| Syngo Carbon Enterprise Access (VA40A) (K240294) | Siemens Healthcare GmbH | 2024-05-23 |
| Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (K232759) | Brainlab AG | 2024-05-21 |
| MIM - Centiloid Scaling (K233620) | Mim Software, Inc. | 2024-05-20 |
| MIM – Monte Carlo Dosimetry (K232862) | Mim Software, Inc. | 2024-05-13 |
| VUZE System (K232976) | Vuze Medical , Ltd. | 2024-05-09 |
| MIM – Dose Analysis (K232514) | Mim Software, Inc. | 2024-05-06 |
| SubtleREFORMAT (1.x) (K233699) | Subtle Medical, Inc. | 2024-04-29 |
| OpenRad Cloud (K240839) | Openrad Services Uk, Ltd. | 2024-04-24 |
| Image Management V15 (K240822) | Philips Medical Systems Technologies | 2024-04-24 |
| Rapid (K233582) | Ischemaview, Inc. | 2024-04-22 |
| Neorad Pacs (Neorad Pacs) (K232641) | Everrtech Software Pvt, Ltd. | 2024-04-10 |
| CARPL (CARPL) (K232891) | Carpl Ai, Inc. | 2024-03-27 |
| Cube Navigator (K240620) | Medical Templates AG | 2024-03-25 |
| nCommand Lite System (K233660) | Ionic Health | 2024-03-18 |
| X-Clever (ASHK100G) (K233599) | Lg Electronics.Inc | 2024-03-18 |
| MRCP+ version 2 (MRCP+ v2) (K233930) | Perspectum | 2024-03-13 |
| Autofuse (K233572) | Pymedix | 2024-03-06 |
| Mimics Cardiac Planner (K233217) | Materialise NV | 2024-02-12 |
| Aid-U (K231662) | Iaid | 2024-02-08 |
| CAAS MR Solutions (K232007) | Pie Medical Imaging BV | 2024-02-01 |
| Augmented Reality Application (K232339) | Sira Medical, Inc. | 2024-02-01 |
| CEPHX- Cephalometric Analysis Software (K231396) | Orca Dental AI , Ltd. | 2024-01-31 |
| BreView (K233714) | GE Medical Systems SCS | 2024-01-25 |
| Axial3D Cloud Segmentation Service (K231607) | Axial Medical Printing Limited | 2024-01-24 |
| FlexView Diagnostic (v1.1.20) (K233226) | Radical Imaging, LLC | 2024-01-17 |
| Horos MD™ (K232589) | Icat Solutions, Ltd. | 2024-01-03 |
| syngo Virtual Cockpit (VB10A) (K232744) | Siemens Healthcare GmbH | 2023-12-21 |
| uOmnispace.MI (K233176) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 |
| syngo Application Software (K230955) | Siemens Medical Solutions USA, Inc. | 2023-12-20 |
| StrokeViewer Perfusion (K231570) | Nico-Lab B.V. | 2023-12-14 |
| TeleScan (K233634) | Bb Imaging | 2023-12-12 |
| DTX Studio Clinic (4.0) (K231898) | Nobel Biocare AB | 2023-12-08 |
| Myocardial Strain Software Application (K232661) | Circle Cardiovascular Imaging | 2023-12-07 |
| TraumaCad Neo (K231498) | Brainlab , Ltd. | 2023-11-20 |
| BrainSpec Core™ Software (K230856) | Brainspec, Inc. | 2023-11-14 |
| SwiftMR (K230854) | Airs Medical, Inc. | 2023-10-27 |
| spineEOS (K232086) | Eos Imaging | 2023-10-24 |
| R2GATE Lite TM (K223909) | Megagen Implant Co., Ltd. | 2023-10-20 |
| EConsole1 (K231225) | DRTECH Corporation | 2023-10-18 |
| Ikshana (K230249) | Immersivetouch | 2023-10-16 |
| Veuron-Brain-pAb3 (K231642) | Heuron Co., Ltd. | 2023-10-13 |
| OFIX MIS App (K230252) | Orthofix US, LLC | 2023-09-26 |
| Jazz (K223659) | Ai Medical AG | 2023-09-22 |
| Rology Teleradiology Platform (v.1.22.1103) (K231385) | Rology, Inc. | 2023-09-20 |
| NEUROShield (K220034) | In-Med Prognostics L3c | 2023-09-14 |
| AccuCTP Pro (K231353) | ArteryFlow Technology Co., Ltd. | 2023-09-14 |
| OrionXR (K232189) | Hoth Intelligence, Inc. | 2023-09-14 |
| UniSyn Molecular Imaging (6-3-1) (K231047) | Convergent Imaging Solutions | 2023-09-01 |
| Brainomix 360 e-MRI (K231656) | Brainomix Limited | 2023-08-30 |
| AIRAscore (K223180) | Airamed GmbH | 2023-08-25 |
| CUPTIMIZE™ Advanced (K231503) | DePuy Orthopaedics, Inc. | 2023-08-22 |
| SaintView (K223660) | Inviz Corporation | 2023-08-14 |
| Efai Pacs Picture Archiving and Communication System Pro (K232100) | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 |
| Patient Specific Planning Solution™ 3D Bone Models (K230540) | Biomet Manufacturing Corp | 2023-07-25 |
| Argus Cognitive ReVISION Software (K223322) | Argus Cognitive, Inc. | 2023-07-24 |
| Fibroid Mapping Reviewer Application (FMRA) (K222683) | Nesa Medtech Private Limited | 2023-07-17 |
| JiveX (Model Number / Release: 5.4) (K231041) | Visus Health IT GmbH | 2023-07-14 |
| Cercare Medical Neurosuite (K230016) | Cercare Medical A/S | 2023-07-14 |
| CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) (K223290) | Sentiar, Inc. | 2023-07-14 |
| XR90 (XR90-SYS) (K223125) | Mediview Xr, Inc. | 2023-07-13 |
| Chondral Quant (K231351) | Siemens Medical Soultions USA, Inc. | 2023-07-13 |
| Pixyl.Neuro (K213253) | Pixyl SA | 2023-06-30 |
| Medisystem Pacs (K223048) | Medilab Manutencao E Sitemas Ltda | 2023-06-23 |
| CT Perfusion V1.0 (K223091) | Olea Medical | 2023-06-09 |
| Ambra PACS (K231360) | Dicom Grid Dba Ambra Health | 2023-06-07 |
| Olea S.I.A. Neurovascular V1.0 (K223532) | Olea Medical | 2023-06-06 |
| Brainomix 360 e-CTP (K223555) | Brainomix Limited | 2023-06-01 |
| KBA3D (K223841) | S.M.A.I.O | 2023-05-30 |
| Quicktome Software Suite (K222359) | Omniscient Neurotechnology Pty Ltd (O8t) | 2023-05-30 |
| Pre-Sure (K230044) | Lazarus 3D | 2023-05-26 |
| Avatar Medical Software V1 (K222035) | Avatar Medical | 2023-05-24 |
| ROSA Hip System (K231162) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-05-23 |
| ADAS 3D (K230803) | Adas3D Medical S.L. | 2023-05-23 |
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