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 |
|---|---|---|---|
| Sep 10, 2021 | K211257 | EFAI PACS Picture Archiving and Communication System Ever Fortune.Ai, Co., Ltd., TW | LLZ |
| Sep 10, 2021 | K202056 | Kinepict Medical Imaging Tool 4.0 Kinepict Health, Ltd., HU | LLZ |
| Sep 3, 2021 | K212421 | ADAS 3D Adas3D Medical S.L., ES | LLZ |
| Aug 27, 2021 | K203696 | RBknee Radiobotics Aps, DK | LLZ |
| Aug 23, 2021 | K211793 | EzOrtho Ewoosoft Co., Ltd., KR | LLZ |
| Aug 20, 2021 | K211791 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Aug 17, 2021 | K210998 | ROSA Hip System Orthosoft D/B/A Zimmer Cas, CA | LLZ |
| Aug 17, 2021 | K201573 | Brain Perfusion (BP) application Philips Medical Systems Nederland B.V., NL | LLZ |
| Aug 16, 2021 | K212230 | TruSPECT Radiological Image Processing Station Spectrum Dynamics Medical, Ltd., IL | LLZ |
| Aug 12, 2021 | K211863 | eVolve PACS Evolve Pacs, Inc. | LLZ |
| Aug 2, 2021 | K212175 | DynaCAD Invivo Corporation | LLZ |
| Jul 27, 2021 | K212074 | ClariCT.AI Claripi, Inc., KR | LLZ |
| Jul 27, 2021 | K211655 | aPROMISE Exini Diagnostics AB, SE | LLZ |
| Jul 27, 2021 | K211279 | Volpara Imaging Software Volpara Health Technologies Limited, NZ | LLZ |
| Jul 23, 2021 | K211386 | MySpine WebPlanner & MyBalance Medacta International S.A., CH | LLZ |
| Jul 20, 2021 | K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray Zirkonzahn Srl, IT | LLZ |
| Jul 8, 2021 | K211480 | NubeX Techheim Co., Ltd., KR | LLZ |
| Jul 8, 2021 | K201835 | PRE-SURE Lazarus 3D, Inc. | LLZ |
| Jul 7, 2021 | K210653 | ONE Planner Hip Orthosoft D/B/A Zimmer Cas, CA | LLZ |
| Jun 25, 2021 | K211656 | 3D Echo v1.1 Jointvue, LLC | LLZ |
| Jun 16, 2021 | K202718 | Qmenta Care Platform Family Mint Labs, Inc., D/B/A. Qmenta | LLZ |
| May 27, 2021 | K200704 | ZedView Lexi Co., Ltd., JP | LLZ |
| May 21, 2021 | K211312 | Universal Viewer GE Healthcare | LLZ |
| May 20, 2021 | K210257 | Xoran Workstation, Model 10050 Xoran Technologies, LLC | LLZ |
| May 19, 2021 | K210187 | Overjet Dental Assist Overjet, Inc. | LLZ |
| May 17, 2021 | K202793 | Cercare Medical Neurosuite Cercare Medical Aps, DK | LLZ |
| May 14, 2021 | K210072 | HOLOSCOPE-i Real View Imaging , Ltd., IL | LLZ |
| May 6, 2021 | K210066 | ImagePilot Konica Minolta, Inc., JP | LLZ |
| May 4, 2021 | K210682 | SOTA Cloud Imaging Sota Precision Optics, Inc. Dba Sota Imaging | LLZ |
| May 4, 2021 | K202521 | PtoleMedic System Lento Medical Innovation, Inc. | LLZ |
| Apr 9, 2021 | K202084 | DeepLook PRECISE Deeplook, Inc. | LLZ |
| Apr 5, 2021 | K210850 | ADAS 3D Adas3D Medical S.L., ES | LLZ |
| Apr 1, 2021 | K203195 | Simpleware ScanIP Medical Synopsys (Northern Europe) , Ltd., GB | LLZ |
| Mar 31, 2021 | K210071 | SIS System (Version 5.1.0) Surgical Information Sciences, Inc. | LLZ |
| Mar 9, 2021 | K203518 | Quicktome Omniscient Neurotechnology Pty Ltd (O8t), AU | LLZ |
| Feb 26, 2021 | K203651 | Cuptimize Cuptimize, Inc. | LLZ |
| Feb 26, 2021 | K203182 | SubtleMR Subtle Medical, Inc. | LLZ |
| Feb 25, 2021 | K202990 | NinesMeasure Nines, Inc. | LLZ |
| Feb 19, 2021 | K202212 | TruPlan Circle Cardiovascular Imaging, Inc., CA | LLZ |
| Feb 19, 2021 | K200589 | MyPAO Planning Report Medacta International S.A., CH | LLZ |
| Feb 18, 2021 | K210136 | PhantomMSK Hip OrthoGrid Systems, Inc. | LLZ |
| Feb 16, 2021 | K203312 | Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation, JP | LLZ |
| Feb 9, 2021 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 Fujifilm Corporation, JP | LLZ |
| Feb 5, 2021 | K203290 | Bonelogic Disior, Ltd., FI | LLZ |
| Feb 4, 2021 | K203582 | QUIBIM Precision Prostate (qp-Prostate) Quibim S.L., ES | LLZ |
| Jan 26, 2021 | K203104 | IBM iConnect Access Merge Healthcare Incorporated | LLZ |
| Jan 15, 2021 | K203677 | ViewPoint 6 GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | LLZ |
| Jan 15, 2021 | K203142 | Veuron-Brain-pAb Heuron Co., Ltd., KR | LLZ |
| Jan 15, 2021 | K202847 | AccuBrain Brainnow Medical Technology Limited, CN | LLZ |
| Jan 7, 2021 | K202414 | BrainInsight Hyperfine Research, Inc. | LLZ |
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