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 |
|---|---|---|---|
| Jun 12, 2015 | K150415 | NilRead Perceptive Software, CA | LLZ |
| Jun 5, 2015 | K150761 | Ez3D-i/E3 Ewoosoft Co., Ltd., KR | LLZ |
| Jun 4, 2015 | K150976 | Collage Anatomage, Inc. | LLZ |
| Jun 3, 2015 | K151115 | MR Core Software Vital Images, Inc. | LLZ |
| Jun 1, 2015 | K143397 | ICIS View Agfa Healthcare N.V., BE | LLZ |
| May 27, 2015 | K150707 | IntelePACS Intelerad Medical Systems Incorporated, CA | LLZ |
| May 26, 2015 | K150420 | Centricity Universal Viewer GE Healthcare | LLZ |
| May 22, 2015 | K150069 | Fine Structure Analysis(fineSA) Acuitas Medical , Ltd., GB | LLZ |
| May 22, 2015 | K142648 | SPINEDESIGN Spine Surgery Planning (Software Application) Medtronic Sofamor Danek USA, Inc. | LLZ |
| Apr 28, 2015 | K142196 | Visage Ease Pro Visage Imaging GmbH, DE | LLZ |
| Apr 24, 2015 | K150843 | syngo®.via (version VB10A) Siemens AG, DE | LLZ |
| Apr 17, 2015 | K142779 | SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED Simpleware , Ltd., GB | LLZ |
| Apr 13, 2015 | K142647 | mint Lesion Mint Medical GmbH, DE | LLZ |
| Apr 6, 2015 | K150738 | VitreaView Vital Images, Inc. | LLZ |
| Apr 2, 2015 | K150747 | EzDent-i /E2/Prora View LK Consulting Group USA, Inc. | LLZ |
| Mar 29, 2015 | K150192 | Scenium Siemens Medical Solutions USA, Inc. | LLZ |
| Mar 26, 2015 | K143361 | Mammo Workstation GE Healthcare, DE | LLZ |
| Mar 24, 2015 | K150193 | Customer Remote Console (CRC) Ge Medical Systems, LLC | LLZ |
| Mar 19, 2015 | K142337 | Blackford Analysis Registration Product Family Blackford Analysis, Ltd., GB | LLZ |
| Mar 10, 2015 | K143318 | DR Systems Zero Download 3D Viewer (Z3D) Dr Systems, Inc. | LLZ |
| Mar 6, 2015 | K141536 | VIEWING CLIENT MOBILE Axon Medical Technologies Corp., CA | LLZ |
| Mar 5, 2015 | K150258 | Vitrea, Version 7.0 Medical Image Processing Software Vital Images, Inc. | LLZ |
| Mar 5, 2015 | K142923 | TraumaCad Mobile Release 1.0 Voyant Health, Ltd., IL | LLZ |
| Mar 2, 2015 | K150085 | GE EchoPAC Ge Vingmed Ultrasound AS, NO | LLZ |
| Feb 24, 2015 | K143319 | Syngo X-workplace SW VD10 Siemens Medi Cal Solutions, Inc. | LLZ |
| Feb 13, 2015 | K150122 | TOMTEC-ARENA TTA2 Tomtec Imaging Systems GmbH, DE | LLZ |
| Feb 6, 2015 | K143044 | CAAS A-Valve Pie Medical Imaging BV, NL | LLZ |
| Feb 4, 2015 | K140828 | NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE Brainreader Aps, DK | LLZ |
| Jan 21, 2015 | K142107 | ECHO TRUE 3D VIEWER Echopixel, Inc. | LLZ |
| Jan 16, 2015 | K141561 | VM PACS WITH VM MEDICAL WORKSTATION Visual Medica, AR | LLZ |
| Jan 6, 2015 | K142850 | McKesson Radiology Mammography Plus Mckesson Medical Imaging Company, CA | LLZ |
| Jan 6, 2015 | K142316 | IMPAX Agility Agfa Healthcare N.V., BE | LLZ |
| Jan 6, 2015 | K140587 | MR-CT VVA Medis Medical Imaging Systems BV, NL | LLZ |
| Dec 18, 2014 | K142514 | UniWeb 8.0 Ebm Technologies Incorporated, TW | LLZ |
| Dec 17, 2014 | K142891 | HEPATIQ Hepatiq, LLC | LLZ |
| Dec 16, 2014 | K142944 | ArthroPlan Digital Templating Software Arthromeda, Inc. | LLZ |
| Dec 16, 2014 | K142919 | EXA Viztek, LLC | LLZ |
| Dec 16, 2014 | K140860 | ImmersiveTouch3 and MicrovisTouch Immersivetouch | LLZ |
| Dec 12, 2014 | K140797 | IPACS MEDICAL IMAGE MANAGEMENT SYSTEM Visbion Limited, GB | LLZ |
| Dec 10, 2014 | K143254 | eSie Apps Suite Siemens Medical Solutions USA, Inc. | LLZ |
| Dec 5, 2014 | K142671 | ONEFIT HIP PLANNER Onefit Medical, FR | LLZ |
| Dec 4, 2014 | K143079 | Endovascular Stent Planning Software Vital Images, Inc. | LLZ |
| Dec 1, 2014 | K142521 | Synapse 3D Liver and Kidney Analysis Fujifilm Meidcal Systems U.S.A.,Inc. | LLZ |
| Oct 31, 2014 | K141881 | RAPIDRESULTS Ramsoft, Inc., CA | LLZ |
| Oct 31, 2014 | K141745 | IQQA-BODYIMAGING SOFTWARE Edda Technology | LLZ |
| Oct 31, 2014 | K141570 | IMPLANT STUDIO 3Shape Medical A/S, DK | LLZ |
| Oct 30, 2014 | K132853 | NOVAPACS Novarad Corp. | LLZ |
| Oct 10, 2014 | K142037 | QUANTRA Hologic, Inc. | LLZ |
| Sep 19, 2014 | K141669 | SURGIMAP Nemaris, Inc. | LLZ |
| Sep 18, 2014 | K141607 | DENTAL IMAGING SOFTWARE Trophy, FR | LLZ |
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