System, Image Processing, Radiological
Regulation 892.2050
50510(k)s in 12 months (2,297 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 |
|---|---|---|---|
| Feb 19, 2014 | K140214 | 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) Jvckenwood Corporation, JP | LLZ |
| Feb 14, 2014 | K140108 | 3MP COLOR LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd., CN | LLZ |
| Feb 14, 2014 | K140103 | 3MP GRAYSCAKE LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd., CN | LLZ |
| Feb 14, 2014 | K133708 | MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR Nec Display Solutions , Ltd., TW | LLZ |
| Feb 6, 2014 | K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION Carestream Health, Inc. | LLZ |
| Jan 31, 2014 | K134002 | 6MP COLOR LCD MONITOR, RADIFORCE RX650 Eizo Corporation, JP | LLZ |
| Jan 31, 2014 | K133730 | CO PILOT/REGIUS UNITEA Konica Minolta, Inc. | LLZ |
| Jan 30, 2014 | K132770 | DOME S10 Nds Surgical Imaging | LLZ |
| Jan 22, 2014 | K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) Invivo Corporation | LLZ |
| Jan 21, 2014 | K132499 | ICRCO CLARITY VIEWER Icrco, Inc. | LLZ |
| Jan 17, 2014 | K133875 | THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA Ortho Kinematics, Inc. | LLZ |
| Jan 6, 2014 | K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) Jvckenwood Corporation, JP | LLZ |
| Jan 3, 2014 | K130998 | SYNGO.VIA WEB VIEWER Siemens AG Medical Solutions, DE | LLZ |
| Dec 26, 2013 | K132095 | OLEA SPHERE Olea Medical, FR | LLZ |
| Dec 24, 2013 | K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING Terarecon,Inc. | LLZ |
| Dec 20, 2013 | K133367 | ORTHOVIS PREOPERATIVE PLAN Custom Orthopaedic Solutions | LLZ |
| Dec 20, 2013 | K132342 | XVWEB Apteryx, Inc. | LLZ |
| Dec 19, 2013 | K133511 | 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) Jvckenwood Corporation, JP | LLZ |
| Dec 16, 2013 | K132963 | FUSIONSYNC, CHIMAERA FUSIONSYNC Chimaera GmbH, DE | LLZ |
| Dec 11, 2013 | K132773 | SIDEXIS 4 Sirona Dental Systems GmbH, DE | LLZ |
| Dec 9, 2013 | K132532 | SYNGO.PLAZA VB10A Siemens AG Healthcare, DE | LLZ |
| Dec 3, 2013 | K133185 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) Jvckenwood Corporation, JP | LLZ |
| Dec 3, 2013 | K133181 | 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) Jvckenwood Corporation, JP | LLZ |
| Dec 3, 2013 | K132742 | M-VU BREAST DENSITY Vucomp, Inc. | LLZ |
| Nov 27, 2013 | K131390 | JUSHA-M52C MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd., CN | LLZ |
| Nov 25, 2013 | K133357 | CHARRUAPACS SYSTEM Charruasoft SA | LLZ |
| Nov 25, 2013 | K132544 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA Tomtec Imaging Systems GmbH, DE | LLZ |
| Nov 7, 2013 | K132799 | CLARISO PACS Clariso, Inc. | LLZ |
| Oct 31, 2013 | K132586 | PAXERAPACS Paxeramed | LLZ |
| Oct 30, 2013 | K132316 | MULTIVIEW Hologic, Inc. | LLZ |
| Oct 25, 2013 | K132188 | MAMMOGRAPHY VIEWER SMV658 Fujifilm Medical System U.S.A., Inc. | LLZ |
| Oct 17, 2013 | K132636 | DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM Smith & Nephew, Inc. | LLZ |
| Oct 4, 2013 | K121447 | ISCHEMA VIEW RAPID Ischemaview, Inc. | LLZ |
| Oct 3, 2013 | K122536 | AMCAD-UT DETECTION MODEL 2.0 Lin & Associates, LLC | LLZ |
| Sep 25, 2013 | K131873 | NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) MethodSense, Inc. | LLZ |
| Sep 24, 2013 | K131685 | GE ECHOPAC Ge Vingmed Ultrasound AS, NO | LLZ |
| Sep 17, 2013 | K131977 | CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE Healthcare | LLZ |
| Sep 12, 2013 | K132302 | QXLINK Vieworks Co., Ltd. | LLZ |
| Sep 6, 2013 | K131389 | JUSHA-C31 MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd., CN | LLZ |
| Sep 5, 2013 | K123944 | KOSTEC MEDICAL GRADE LDC MONITORS Kostec Co., Ltd. | LLZ |
| Sep 4, 2013 | K132610 | 5MP GRAYSCALE LCD DISPLAY Shenzhen Beacon Display Technology Co., Ltd., CN | LLZ |
| Aug 29, 2013 | K132587 | MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR Ned Display Solutions , Ltd., JP | LLZ |
| Aug 29, 2013 | K131616 | EZ3D-I, E3 Ewoosoft Co., Ltd. | LLZ |
| Aug 29, 2013 | K131594 | EZDENTI-I; E2; PRORA VIEW Ewoosoft Co., Ltd. | LLZ |
| Aug 29, 2013 | K130374 | OMNI-VUE 2 SYSTEM Genesis Digital Imaging, Inc. | LLZ |
| Aug 29, 2013 | K130242 | MAVEN PRO Nsequence | LLZ |
| Aug 21, 2013 | K131391 | JUSHA-M32 MEDICAL DISPLAY Nanjing Jusha Display Technology Co., Ltd., CN | LLZ |
| Aug 21, 2013 | K131158 | CORVIEW Marrek, Inc. | LLZ |
| Aug 20, 2013 | K130749 | SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR Siemens Medical Solutions USA, Inc. | LLZ |
| Aug 15, 2013 | K131570 | ORTHOVISION Ewoosoft Co., Ltd. | LLZ |
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