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 |
|---|---|---|
| Autoplaque (K212758) | Cedars-Sinai Medical Center: Aim | 2023-05-19 |
| iTFlow (K222854) | Cardio Flow Design, Inc. | 2023-05-12 |
| SubtleMR (2.3.x) (K223623) | Subtle Medical, Inc. | 2023-05-11 |
| Akunah REFLECT (K222987) | Akunah Pty, Ltd. | 2023-05-10 |
| Neurophet AQUA (K220437) | Neurophet., Inc. | 2023-05-10 |
| 3D Anatomic Model (K230119) | Ricoh USA, Inc. | 2023-05-02 |
| CarnaLife Holo (K221870) | Medapp S.A. | 2023-05-01 |
| MR DWI/FLAIR Measurement V1.0 (K230552) | Olea Medical | 2023-04-26 |
| Konicaminolta DI-X1 (K230906) | Konica Minolta, Inc. | 2023-04-25 |
| EzDent Web (K230468) | Ewoosoft Co., Ltd. | 2023-04-21 |
| Quantib Prostate (K230772) | Quantib B.V. | 2023-04-17 |
| Ezra Flash (K230264) | Ezra Ai, Inc. | 2023-04-13 |
| UniCam Evo Software (K230393) | Inter Medical Medizintechnik GmbH | 2023-04-13 |
| Augmento (K222781) | Deeptek Medical Imaging Private Limited | 2023-04-11 |
| Limbus Contour (K230575) | Limbus Ai, Inc. | 2023-04-07 |
| RadAlly (K213660) | Imaging Wave, LLC | 2023-03-31 |
| CereFlow™ V1.2 (K211059) | Translational Mri, LLC | 2023-03-31 |
| InterView XP; InterView FUSION (K221984) | Mediso Medical Imaging Systems, Lttd. | 2023-03-29 |
| Syngo Carbon Space VA30A (K230561) | Siemens Healthcare GmbH | 2023-03-21 |
| FlightPlan for Embolization (K223490) | GE Medical Systems SCS | 2023-03-21 |
| CoverScan (CoverScan v1.1) (K230294) | Perspectum | 2023-03-03 |
| Advantis Platform (K222975) | Advantis Medical Imaging Single Member P.C. | 2023-03-01 |
| Xeleris V Processing and Review System (K221680) | GE Healthcare | 2023-03-01 |
| RealNow (K213891) | Yiwei Medical Technology Co., Ltd. | 2023-02-24 |
| Clarus Viewer (K222757) | Clarus Viewer Corporation | 2023-02-24 |
| EzDent-i / E2 / Prora View/ Smart M Viewer (K223820) | Ewoosoft Co., Ltd. | 2023-02-17 |
| syngo.via View&GO VA40A (K230196) | Siemens Healthcare GmbH | 2023-02-13 |
| MD.ai Viewer (K223425) | Mdai, Inc. | 2023-02-10 |
| Atomica Planner (K230012) | Atomica Technology, Inc. | 2023-02-02 |
| Advanced MyHip Planner (K221725) | Medacta International S.A. | 2023-01-20 |
| PerfusionGo Plus (K221627) | Yukun (Beijing) Technology Co., Ltd. | 2023-01-19 |
| TruPlan Computed Tomography (CT) Imaging Software (K222593) | Circle Cardiovascular Imaging, Inc. | 2023-01-18 |
| Elucis (K220649) | Realize Medical, Inc. | 2023-01-17 |
| MIM – Additional Tracers (K223800) | Mim Software, Inc. | 2023-01-17 |
| MR Diffusion Perfusion Mismatch V1.0 (K223502) | Olea Medical | 2023-01-13 |
| MAMMOVISTA B.smart (VB70) (K223363) | Siemens Medical Solutions USA, Inc. | 2023-01-12 |
| AIBOLIT 3D+ (K222458) | Aibolit Technologies, LLC | 2023-01-12 |
| Vitrea Software Package, VSTP-002A (K223336) | Canon Medical Systems Corporation | 2023-01-09 |
| TECHFIT Diagnostic Models (K222577) | Techfit Digital Surgery, Inc. | 2023-01-06 |
| OnyxCeph (K213263) | Image Instruments GmbH | 2023-01-04 |
| PeekMed web (v1) (K222767) | Peek Health, S.A. | 2022-12-30 |
| Cyware 4H and Cysart 4H (K221796) | Abys Medical | 2022-12-30 |
| aprevo® Digital Workflow (K222195) | Carlsmed, Inc. | 2022-12-30 |
| Xenoview VDP (K223071) | Polarean, Inc. | 2022-12-23 |
| MedDream (K222320) | Softneta Uab | 2022-12-06 |
| TorchTM Software (K220630) | Voximetry, Incorporated | 2022-11-28 |
| VSI HoloMedicine (K213215) | Apoqlar GmbH | 2022-11-25 |
| Denti.AI Auto-Chart (K222054) | Denti.Ai Technology, Inc. | 2022-11-22 |
| Vision 2, EVARVision, TrackVision 2, HeartVision 2 (K223152) | GE Medical Systems SCS | 2022-11-22 |
| AccuCTP (K220663) | ArteryFlow Technology Co., Ltd. | 2022-11-22 |
| Minimally Invasive Prostate Surgery Navigation System (K221499) | Augment Intelligent Medical System (China) Co., Ltd. | 2022-11-22 |
| OmegaAI Image Viewer (K222476) | Ramsoft, Inc. | 2022-11-17 |
| Synapse 3D Base Tools v6.6 (K221677) | Fujifilm Corporation | 2022-11-10 |
| Dolphin Blue Imaging (K221478) | Patterson Dental Supply, Inc. | 2022-11-01 |
| 3Dicom MD (K222470) | Singular Health Pty, Ltd. | 2022-10-25 |
| IntraOp VSP Software Device (K213128) | Xironetic, LLC | 2022-10-21 |
| Vitrea CT Cardiac Analysis (K222662) | Canon Medical Informatics, Inc. | 2022-10-14 |
| syngo.via View&GO (K221501) | Siemens Healthcare GmbH | 2022-10-14 |
| e-Ortho Shoulder Software v1.1 (K220758) | FH Industrie | 2022-09-30 |
| Ez3D-i/E3 (K222069) | Ewoosoft Co., Ltd. | 2022-09-06 |
| AXIR-CX (K213520) | Radisen Co., Ltd. | 2022-08-19 |
| WebCeph (K220903) | Assemblecircle Corp. | 2022-08-17 |
| syngo Application Software (VE21) (K220433) | Siemens Medical Solution USA, Inc. | 2022-08-16 |
| EzDent-i / E2 / Prora View/ Smart M Viewer (K222145) | Ewoosoft Co., Ltd. | 2022-08-12 |
| TeraRecon Neuro (K220349) | Terarecon,Inc. | 2022-08-12 |
| Dolphin Imaging 12.0 (K222072) | Patterson Dental Supply, Inc. | 2022-08-08 |
| Neurophet SCALE PET (K221405) | Neurophet., Inc. | 2022-08-05 |
| AI4CMR v1.0 (K220624) | Ai4medimaging Medical Solutions S.A. | 2022-07-22 |
| FX SPS (K213922) | Pixee Medical | 2022-07-22 |
| AutoSeg (K220039) | Ai Medic, Inc. | 2022-07-20 |
| Functional MR V1.0 (K221426) | Olea Medical S.A.S. | 2022-07-06 |
| Axial3D Cloud Segmentation Service (K221511) | Axial Medical Printing Limited | 2022-06-23 |
| Syngo Carbon Space VA20A (K213665) | Siemens Healthcare GmbH | 2022-06-21 |
| ElucidVivo A.3 (K221463) | Elucid Bioimaging, Inc. | 2022-06-17 |
| SurgiCase Viewer (K213684) | Materialise NV | 2022-06-15 |
| MediLab (K221065) | Sigma Scientific Services, LLC | 2022-06-10 |
| 3D Anatomic Models (K220205) | Ricoh USA, Inc. | 2022-06-03 |
| EchoNavigator R4.0 (K221270) | Philips Medical Systems Nederland B.V. | 2022-05-31 |
| SwiftMR (K220416) | Airs Medical, Inc. | 2022-05-25 |
| ON3D (K221000) | 3D Ons, Inc. | 2022-05-23 |
| syngo Dynamics (Version VA40E) (K220832) | Siemens Medical Solutions USA, Inc. | 2022-05-20 |
| CoverScan v1 (K212565) | Perspectum, Ltd. | 2022-05-19 |
| Caas Qardia (K212376) | Pie Medical Imaging BV | 2022-05-16 |
| Quantib Prostate (K221106) | Quantib B.V. | 2022-05-13 |
| inHEART MODELS (K220727) | Inheart, Sas | 2022-05-10 |
| KEOPS Balance Analyzer 3D (K213975) | S.M.A.I.O | 2022-05-06 |
| Segment 3DPrint (K211966) | Medviso AB | 2022-05-06 |
| exoplan (K213302) | Exocad GmbH | 2022-05-03 |
| aPROMISE X (K220590) | Exini Diagnostics AB | 2022-04-29 |
| Oryx Cloud Imaging (K220684) | Oryx Dental Software, Inc. | 2022-04-29 |
| AngioCloud Service (K211713) | Angiocloud, LLC | 2022-04-28 |
| MirrorMe3D Modeling System (K212981) | Mirrorme3D, LLC | 2022-04-22 |
| XD (K220779) | Mirada Medical, Ltd. | 2022-04-15 |
| TeleScan (K220767) | Bb Imaging | 2022-04-14 |
| ClariPulmo (K203783) | Claripi, Inc. | 2022-04-06 |
| DTX Studio Clinic 3.0 (K213562) | Nobel Biocare AB | 2022-03-25 |
| RI.HIP MODELER (K212040) | Blue Belt Technologies, Inc. | 2022-03-11 |
| nordicDSC (K212720) | Nordicneurolab AS | 2022-03-03 |
| EzOrtho v1.3 (K220003) | Ewoosoft Co., Ltd. | 2022-02-23 |
| Rapid (K213165) | Ischemaview, Inc. | 2022-02-08 |
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