System, Image Processing, Radiological
Regulation 892.2050
48510(k)s in 12 months (2,295 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2024 | K232891 | CARPL (CARPL) Carpl Ai, Inc. | LLZ |
| Mar 25, 2024 | K240620 | Cube Navigator Medical Templates AG, CH | LLZ |
| Mar 18, 2024 | K233660 | nCommand Lite System Ionic Health, BR | LLZ |
| Mar 18, 2024 | K233599 | X-Clever (ASHK100G) Lg Electronics.Inc, KR | LLZ |
| Mar 13, 2024 | K233930 | MRCP+ version 2 (MRCP+ v2) Perspectum, GB | LLZ |
| Mar 6, 2024 | K233572 | Autofuse Pymedix | LLZ |
| Feb 12, 2024 | K233217 | Mimics Cardiac Planner Materialise NV, BE | LLZ |
| Feb 8, 2024 | K231662 | Aid-U Iaid, KR | LLZ |
| Feb 1, 2024 | K232339 | Augmented Reality Application Sira Medical, Inc. | LLZ |
| Feb 1, 2024 | K232007 | CAAS MR Solutions Pie Medical Imaging BV, NL | LLZ |
| Jan 31, 2024 | K231396 | CEPHX- Cephalometric Analysis Software Orca Dental AI , Ltd., IL | LLZ |
| Jan 25, 2024 | K233714 | BreView GE Medical Systems SCS, FR | LLZ |
| Jan 24, 2024 | K231607 | Axial3D Cloud Segmentation Service Axial Medical Printing Limited, GB | LLZ |
| Jan 17, 2024 | K233226 | FlexView Diagnostic (v1.1.20) Radical Imaging, LLC | LLZ |
| Jan 3, 2024 | K232589 | Horos MD Icat Solutions, Ltd., GB | LLZ |
| Dec 21, 2023 | K232744 | syngo Virtual Cockpit (VB10A) Siemens Healthcare GmbH, DE | LLZ |
| Dec 20, 2023 | K233176 | uOmnispace.MI Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Dec 20, 2023 | K230955 | syngo Application Software Siemens Medical Solutions USA, Inc. | LLZ |
| Dec 14, 2023 | K231570 | StrokeViewer Perfusion Nico-Lab B.V., NL | LLZ |
| Dec 12, 2023 | K233634 | TeleScan Bb Imaging | LLZ |
| Dec 8, 2023 | K231898 | DTX Studio Clinic (4.0) Nobel Biocare AB, SE | LLZ |
| Dec 7, 2023 | K232661 | Myocardial Strain Software Application Circle Cardiovascular Imaging, CA | LLZ |
| Nov 20, 2023 | K231498 | TraumaCad Neo Brainlab , Ltd., IL | LLZ |
| Nov 14, 2023 | K230856 | BrainSpec Core Software Brainspec, Inc. | LLZ |
| Oct 27, 2023 | K230854 | SwiftMR Airs Medical, Inc., KR | LLZ |
| Oct 24, 2023 | K232086 | spineEOS Eos Imaging, FR | LLZ |
| Oct 20, 2023 | K223909 | R2GATE Lite TM Megagen Implant Co., Ltd., KR | LLZ |
| Oct 18, 2023 | K231225 | EConsole1 DRTECH Corporation, KR | LLZ |
| Oct 16, 2023 | K230249 | Ikshana Immersivetouch | LLZ |
| Oct 13, 2023 | K231642 | Veuron-Brain-pAb3 Heuron Co., Ltd., KR | LLZ |
| Sep 26, 2023 | K230252 | OFIX MIS App Orthofix US, LLC | LLZ |
| Sep 22, 2023 | K223659 | Jazz Ai Medical AG, CH | LLZ |
| Sep 20, 2023 | K231385 | Rology Teleradiology Platform (v.1.22.1103) Rology, Inc. | LLZ |
| Sep 14, 2023 | K232189 | OrionXR Hoth Intelligence, Inc. | LLZ |
| Sep 14, 2023 | K231353 | AccuCTP Pro ArteryFlow Technology Co., Ltd., CN | LLZ |
| Sep 14, 2023 | K220034 | NEUROShield In-Med Prognostics L3c | LLZ |
| Sep 1, 2023 | K231047 | UniSyn Molecular Imaging (6-3-1) Convergent Imaging Solutions, CA | LLZ |
| Aug 30, 2023 | K231656 | Brainomix 360 e-MRI Brainomix Limited, GB | LLZ |
| Aug 25, 2023 | K223180 | AIRAscore Airamed GmbH, DE | LLZ |
| Aug 22, 2023 | K231503 | CUPTIMIZE Advanced DePuy Orthopaedics, Inc. | LLZ |
| Aug 14, 2023 | K223660 | SaintView Inviz Corporation, KR | LLZ |
| Aug 8, 2023 | K232100 | Efai Pacs Picture Archiving and Communication System Pro Ever Fortune.Ai, Co., Ltd., TW | LLZ |
| Jul 25, 2023 | K230540 | Patient Specific Planning Solution 3D Bone Models Biomet Manufacturing Corp | LLZ |
| Jul 24, 2023 | K223322 | Argus Cognitive ReVISION Software Argus Cognitive, Inc. | LLZ |
| Jul 17, 2023 | K222683 | Fibroid Mapping Reviewer Application (FMRA) Nesa Medtech Private Limited, IN | LLZ |
| Jul 14, 2023 | K231041 | JiveX (Model Number / Release: 5.4) Visus Health IT GmbH, DE | LLZ |
| Jul 14, 2023 | K230016 | Cercare Medical Neurosuite Cercare Medical A/S, DK | LLZ |
| Jul 14, 2023 | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) Sentiar, Inc. | LLZ |
| Jul 13, 2023 | K231351 | Chondral Quant Siemens Medical Soultions USA, Inc. | LLZ |
| Jul 13, 2023 | K223125 | XR90 (XR90-SYS) Mediview Xr, Inc. | LLZ |
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