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 3 of 23
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223091 | CT Perfusion V1.0 | Olea Medical | 2023-06-09 | Traditional | PDF ↗ |
| K231360 | Ambra PACS | Dicom Grid Dba Ambra Health | 2023-06-07 | Special | PDF ↗ |
| K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023-06-06 | Traditional | PDF ↗ |
| K223555 | Brainomix 360 e-CTP | Brainomix Limited | 2023-06-01 | Traditional | PDF ↗ |
| K222359 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (O8t) | 2023-05-30 | Traditional | PDF ↗ |
| K223841 | KBA3D | S.M.A.I.O | 2023-05-30 | Traditional | PDF ↗ |
| K230044 | Pre-Sure | Lazarus 3D | 2023-05-26 | Traditional | PDF ↗ |
| K222035 | Avatar Medical Software V1 | Avatar Medical | 2023-05-24 | Traditional | PDF ↗ |
| K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-05-23 | Special | PDF ↗ |
| K230803 | ADAS 3D | Adas3D Medical S.L. | 2023-05-23 | Special | PDF ↗ |
| K212758 | Autoplaque | Cedars-Sinai Medical Center: Aim | 2023-05-19 | Traditional | PDF ↗ |
| K222854 | iTFlow | Cardio Flow Design, Inc. | 2023-05-12 | Traditional | PDF ↗ |
| K223623 | SubtleMR (2.3.x) | Subtle Medical, Inc. | 2023-05-11 | Traditional | PDF ↗ |
| K222987 | Akunah REFLECT | Akunah Pty, Ltd. | 2023-05-10 | Traditional | PDF ↗ |
| K220437 | Neurophet AQUA | Neurophet., Inc. | 2023-05-10 | Traditional | PDF ↗ |
| K230119 | 3D Anatomic Model | Ricoh USA, Inc. | 2023-05-02 | Traditional | PDF ↗ |
| K221870 | CarnaLife Holo | Medapp S.A. | 2023-05-01 | Traditional | PDF ↗ |
| K230552 | MR DWI/FLAIR Measurement V1.0 | Olea Medical | 2023-04-26 | Traditional | PDF ↗ |
| K230906 | Konicaminolta DI-X1 | Konica Minolta, Inc. | 2023-04-25 | Special | PDF ↗ |
| K230468 | EzDent Web | Ewoosoft Co., Ltd. | 2023-04-21 | Traditional | PDF ↗ |
| K230772 | Quantib Prostate | Quantib B.V. | 2023-04-17 | Special | PDF ↗ |
| K230393 | UniCam Evo Software | Inter Medical Medizintechnik GmbH | 2023-04-13 | Traditional | PDF ↗ |
| K230264 | Ezra Flash | Ezra Ai, Inc. | 2023-04-13 | Traditional | PDF ↗ |
| K222781 | Augmento | Deeptek Medical Imaging Private Limited | 2023-04-11 | Traditional | PDF ↗ |
| K230575 | Limbus Contour | Limbus Ai, Inc. | 2023-04-07 | Special | PDF ↗ |
| K211059 | CereFlow V1.2 | Translational Mri, LLC | 2023-03-31 | Traditional | PDF ↗ |
| K213660 | RadAlly | Imaging Wave, LLC | 2023-03-31 | Abbreviated | PDF ↗ |
| K221984 | InterView XP; InterView FUSION | Mediso Medical Imaging Systems, Lttd. | 2023-03-29 | Traditional | PDF ↗ |
| K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | 2023-03-21 | Traditional | PDF ↗ |
| K223490 | FlightPlan for Embolization | GE Medical Systems SCS | 2023-03-21 | Traditional | PDF ↗ |
| K230294 | CoverScan (CoverScan v1.1) | Perspectum | 2023-03-03 | Special | PDF ↗ |
| K222975 | Advantis Platform | Advantis Medical Imaging Single Member P.C. | 2023-03-01 | Traditional | PDF ↗ |
| K221680 | Xeleris V Processing and Review System | GE Healthcare | 2023-03-01 | Traditional | PDF ↗ |
| K213891 | RealNow | Yiwei Medical Technology Co., Ltd. | 2023-02-24 | Traditional | PDF ↗ |
| K222757 | Clarus Viewer | Clarus Viewer Corporation | 2023-02-24 | Traditional | PDF ↗ |
| K223820 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2023-02-17 | Traditional | PDF ↗ |
| K230196 | syngo.via View&GO VA40A | Siemens Healthcare GmbH | 2023-02-13 | Traditional | PDF ↗ |
| K223425 | MD.ai Viewer | Mdai, Inc. | 2023-02-10 | Traditional | PDF ↗ |
| K230012 | Atomica Planner | Atomica Technology, Inc. | 2023-02-02 | Traditional | PDF ↗ |
| K221725 | Advanced MyHip Planner | Medacta International S.A. | 2023-01-20 | Traditional | PDF ↗ |
| K221627 | PerfusionGo Plus | Yukun (Beijing) Technology Co., Ltd. | 2023-01-19 | Traditional | PDF ↗ |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023-01-18 | Traditional | PDF ↗ |
| K220649 | Elucis | Realize Medical, Inc. | 2023-01-17 | Traditional | PDF ↗ |
| K223800 | MIM Additional Tracers | Mim Software, Inc. | 2023-01-17 | Special | PDF ↗ |
| K223502 | MR Diffusion Perfusion Mismatch V1.0 | Olea Medical | 2023-01-13 | Traditional | PDF ↗ |
| K222458 | AIBOLIT 3D+ | Aibolit Technologies, LLC | 2023-01-12 | Traditional | PDF ↗ |
| K223363 | MAMMOVISTA B.smart (VB70) | Siemens Medical Solutions USA, Inc. | 2023-01-12 | Special | PDF ↗ |
| K223336 | Vitrea Software Package, VSTP-002A | Canon Medical Systems Corporation | 2023-01-09 | Traditional | PDF ↗ |
| K222577 | TECHFIT Diagnostic Models | Techfit Digital Surgery, Inc. | 2023-01-06 | Traditional | PDF ↗ |
| K213263 | OnyxCeph | Image Instruments GmbH | 2023-01-04 | Traditional | PDF ↗ |
| K222767 | PeekMed web (v1) | Peek Health, S.A. | 2022-12-30 | Traditional | PDF ↗ |
| K222195 | aprevo® Digital Workflow | Carlsmed, Inc. | 2022-12-30 | Traditional | PDF ↗ |
| K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022-12-30 | Traditional | PDF ↗ |
| K223071 | Xenoview VDP | Polarean, Inc. | 2022-12-23 | Traditional | PDF ↗ |
| K222320 | MedDream | Softneta Uab | 2022-12-06 | Traditional | PDF ↗ |
| K220630 | TorchTM Software | Voximetry, Incorporated | 2022-11-28 | Traditional | PDF ↗ |
| K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022-11-25 | Traditional | PDF ↗ |
| K222054 | Denti.AI Auto-Chart | Denti.Ai Technology, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K221499 | Minimally Invasive Prostate Surgery Navigation System | Augment Intelligent Medical System (China) Co., Ltd. | 2022-11-22 | Traditional | PDF ↗ |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | GE Medical Systems SCS | 2022-11-22 | Traditional | PDF ↗ |
| K220663 | AccuCTP | ArteryFlow Technology Co., Ltd. | 2022-11-22 | Traditional | PDF ↗ |
| K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K221677 | Synapse 3D Base Tools v6.6 | Fujifilm Corporation | 2022-11-10 | Traditional | PDF ↗ |
| K221478 | Dolphin Blue Imaging | Patterson Dental Supply, Inc. | 2022-11-01 | Traditional | PDF ↗ |
| K222470 | 3Dicom MD | Singular Health Pty, Ltd. | 2022-10-25 | Traditional | PDF ↗ |
| K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022-10-21 | Traditional | PDF ↗ |
| K222662 | Vitrea CT Cardiac Analysis | Canon Medical Informatics, Inc. | 2022-10-14 | Special | PDF ↗ |
| K221501 | syngo.via View&GO | Siemens Healthcare GmbH | 2022-10-14 | Traditional | PDF ↗ |
| K220758 | e-Ortho Shoulder Software v1.1 | FH Industrie | 2022-09-30 | Traditional | PDF ↗ |
| K222069 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2022-09-06 | Traditional | PDF ↗ |
| K213520 | AXIR-CX | Radisen Co., Ltd. | 2022-08-19 | Traditional | PDF ↗ |
| K220903 | WebCeph | Assemblecircle Corp. | 2022-08-17 | Traditional | PDF ↗ |
| K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | 2022-08-16 | Traditional | PDF ↗ |
| K220349 | TeraRecon Neuro | Terarecon,Inc. | 2022-08-12 | Traditional | PDF ↗ |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd. | 2022-08-12 | Traditional | PDF ↗ |
| K222072 | Dolphin Imaging 12.0 | Patterson Dental Supply, Inc. | 2022-08-08 | Special | PDF ↗ |
| K221405 | Neurophet SCALE PET | Neurophet., Inc. | 2022-08-05 | Traditional | PDF ↗ |
| K220624 | AI4CMR v1.0 | Ai4medimaging Medical Solutions S.A. | 2022-07-22 | Traditional | PDF ↗ |
| K213922 | FX SPS | Pixee Medical | 2022-07-22 | Traditional | PDF ↗ |
| K220039 | AutoSeg | Ai Medic, Inc. | 2022-07-20 | Traditional | PDF ↗ |
| K221426 | Functional MR V1.0 | Olea Medical S.A.S. | 2022-07-06 | Traditional | PDF ↗ |
| K221511 | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | 2022-06-23 | Traditional | PDF ↗ |
| K213665 | Syngo Carbon Space VA20A | Siemens Healthcare GmbH | 2022-06-21 | Traditional | PDF ↗ |
| K221463 | ElucidVivo A.3 | Elucid Bioimaging, Inc. | 2022-06-17 | Special | PDF ↗ |
| K213684 | SurgiCase Viewer | Materialise NV | 2022-06-15 | Traditional | PDF ↗ |
| K221065 | MediLab | Sigma Scientific Services, LLC | 2022-06-10 | Traditional | PDF ↗ |
| K220205 | 3D Anatomic Models | Ricoh USA, Inc. | 2022-06-03 | Traditional | PDF ↗ |
| K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | 2022-05-31 | Special | PDF ↗ |
| K220416 | SwiftMR | Airs Medical, Inc. | 2022-05-25 | Traditional | PDF ↗ |
| K221000 | ON3D | 3D Ons, Inc. | 2022-05-23 | Traditional | PDF ↗ |
| K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | 2022-05-20 | Traditional | PDF ↗ |
| K212565 | CoverScan v1 | Perspectum, Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K212376 | Caas Qardia | Pie Medical Imaging BV | 2022-05-16 | Traditional | PDF ↗ |
| K221106 | Quantib Prostate | Quantib B.V. | 2022-05-13 | Special | PDF ↗ |
| K220727 | inHEART MODELS | Inheart, Sas | 2022-05-10 | Traditional | PDF ↗ |
| K213975 | KEOPS Balance Analyzer 3D | S.M.A.I.O | 2022-05-06 | Traditional | PDF ↗ |
| K211966 | Segment 3DPrint | Medviso AB | 2022-05-06 | Traditional | PDF ↗ |
| K213302 | exoplan | Exocad GmbH | 2022-05-03 | Traditional | PDF ↗ |
| K220684 | Oryx Cloud Imaging | Oryx Dental Software, Inc. | 2022-04-29 | Traditional | PDF ↗ |
| K220590 | aPROMISE X | Exini Diagnostics AB | 2022-04-29 | Traditional | PDF ↗ |
Product code LLZ · Class II · Radiology. Data: openFDA.