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 |
|---|---|---|---|
| Oct 18, 2019 | K191544 | Synapse 3D Blood Flow Analysis Fujifilm Corporation, JP | LLZ |
| Oct 17, 2019 | K192455 | Merge PACS Merge Healthcare Incorporated | LLZ |
| Oct 17, 2019 | K191216 | Voxel Dosimetry v1.0 Hermes Medical Solutions AB, SE | LLZ |
| Oct 17, 2019 | K190162 | SmartCeph Ortho2, LLC | LLZ |
| Oct 16, 2019 | K191493 | Ventripoint Medical System Plus (VMS+) 3.0 Ventripoint Diagnostics , Ltd., CA | LLZ |
| Oct 9, 2019 | K192200 | DynaCAD Invivo Corporation | LLZ |
| Oct 1, 2019 | K191610 | RTapp Segana, LLC | LLZ |
| Sep 26, 2019 | K192435 | NuVasive NuvaLine Nu Vasive, Incorporated | LLZ |
| Sep 26, 2019 | K191530 | StoneChecker Imaging Biometrics, LLC | LLZ |
| Sep 20, 2019 | K192276 | Merge Cardio Merge Healthcare Incorporated | LLZ |
| Sep 16, 2019 | K191688 | SubtleMR Subtle Medical, Inc. | LLZ |
| Sep 13, 2019 | K192304 | SIS Software Version 3.6.0 Surgical Information Sciences, Inc. | LLZ |
| Sep 12, 2019 | K190780 | syngo Application Software Siemens Medical Solution USA, Inc. | LLZ |
| Aug 29, 2019 | K183489 | D2P 3D Systems, Inc., IL | LLZ |
| Aug 23, 2019 | K183544 | Efficient Care 3D Planning Orthosoft Inc (D/B/A Zimmer Cas), CA | LLZ |
| Aug 6, 2019 | K183458 | exoplan 2.3 Exocad GmbH, DE | LLZ |
| Aug 5, 2019 | K191262 | aBSI Exini Diagnostics AB, SE | LLZ |
| Aug 1, 2019 | K183193 | MREplus+ Software Resoundant, Inc. | LLZ |
| Jul 19, 2019 | K191309 | syngo.via MI Workflows VB40A, Scenium Siemens Medical Soultions USA, Inc. | LLZ |
| Jul 12, 2019 | K191585 | iNtuition-Structural Heart Module Terarecon,Inc. | LLZ |
| Jul 11, 2019 | K190694 | Unifi Workspace v1.0.0 Hologic, Inc. | LLZ |
| Jul 5, 2019 | K182904 | syngo.MR Applications Siemens Medical Solutions USA, Inc. | LLZ |
| Jun 26, 2019 | K190096 | R2GATE Megagen Implant Co., Ltd., KR | LLZ |
| Jun 24, 2019 | K183170 | uWS-CT Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Jun 18, 2019 | K190913 | QLAB Advanced Quantification Software 13 Philips Health Care | LLZ |
| Jun 13, 2019 | K183460 | ClariCT.AI Claripi, Inc., KR | LLZ |
| Jun 5, 2019 | K190874 | Materialise Mimics Enlight Materialise NV, BE | LLZ |
| May 30, 2019 | K191188 | ASHK100G Lg Electronics, KR | LLZ |
| May 16, 2019 | K191040 | syngo.via (Version VB40A) Siemens Healthcare GmbH, DE | LLZ |
| May 13, 2019 | K190764 | SurgicalAR Medivis, Inc. | LLZ |
| Apr 30, 2019 | K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) Rayence Co., Ltd., KR | LLZ |
| Apr 25, 2019 | K190042 | Brainlab Elements Image Fusion Angio Brainlab AG, DE | LLZ |
| Apr 25, 2019 | K183248 | Synapse Enterprise Viewer Version 1.0 Fujifilm Corporation, JP | LLZ |
| Apr 19, 2019 | K190791 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Apr 18, 2019 | K183593 | Lung Vision System Bodyvision Medical , Ltd., IL | LLZ |
| Apr 15, 2019 | K190420 | NDOHD High Definition Imaging System (NDOHD) Altaravision, Inc. | LLZ |
| Apr 12, 2019 | K182572 | InstaRISPACS / InstaZFP / InstaMobi v5.0 Meddiff Technologies Pvt. , Ltd., IN | LLZ |
| Apr 1, 2019 | K190629 | DBSWIN and VISTAEASY Imaging Software Durr Dental SE, DE | LLZ |
| Mar 29, 2019 | K183210 | Thoracic VCAR with GSI Pulmonary Perfusion GE Medical Systems SCS, FR | LLZ |
| Mar 27, 2019 | K183105 | Mimics Medical Materialise NV, BE | LLZ |
| Mar 26, 2019 | K190232 | Synapse PACS Fujifilm Corporation, JP | LLZ |
| Mar 22, 2019 | K183164 | uWS-MR Shanghai United Imaging Healthcare Co., Ltd., CN | LLZ |
| Mar 19, 2019 | K190379 | MIM on Linux Mim Software, Inc. | LLZ |
| Mar 19, 2019 | K183019 | SIS Software version 3.3.0 Surgical Information Sciences, Inc. | LLZ |
| Mar 8, 2019 | K182537 | RADMAX Digital Imaging Software DRGEM Corporation, KR | LLZ |
| Mar 6, 2019 | K182966 | PLANET Onco Dose Dosisoft, FR | LLZ |
| Mar 6, 2019 | K181859 | Visualase Thermal Therapy System Medtronic Navigation, Inc. | LLZ |
| Mar 1, 2019 | K183478 | ClearON Mobile Rayence Co., Ltd., KR | LLZ |
| Feb 27, 2019 | K190087 | EzDent-i / E2 / Prora View Ewoosoft Co., Ltd., KR | LLZ |
| Feb 22, 2019 | K182643 | IRIS 1.0 System Intuitive Surgical | LLZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.