System, X-Ray, Mobile
Regulation 892.1720
7510(k)s in 12 months (238 all time)
5recalls in 12 months (173 all time)
161recalls that name a 510(k)
Top companies in IZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Sedecal USA, Inc. | 19 | 58 |
| Siemens Medical Solutions | 6 | 18 |
| Carestream Health | 7 | 13 |
| GE Medical Systems | 8 | 10 |
| Minxray, Inc. | 15 | 0 |
| GE Healthcare | 0 | 14 |
| Micro-X , Ltd. | 2 | 10 |
| General X-Ray, Inc. | 11 | 0 |
| Shimadzu Medical Systems | 1 | 8 |
| Samsung Electronics Co., Ltd. | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2015 | K150097 | GM60A-32S & GM60A-40S Samsung Electronics Co., Ltd., KR | IZL |
| Dec 17, 2014 | K142492 | GM60A-32S, GM60A-40S Samsung Electronics Co., Ltd., KR | IZL |
| Oct 29, 2014 | K141539 | KUBTEC X250 Kub Technologies, Inc. | IZL |
| Sep 25, 2014 | K142383 | Optima XR200amx, Optima XR220amx Ge Medical Systems, LLC | IZL |
| Sep 18, 2014 | K141895 | MOBILEDIAGNOST WDR Sedecal., Sa. | IZL |
| Sep 18, 2014 | K141885 | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY Minxray, Inc. | IZL |
| Aug 19, 2014 | K140723 | NOMAD MD 75K V HANDHELD X-RAY SYSTEM Aribex, Inc. | IZL |
| Mar 28, 2014 | K122298 | AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR Ajex Meditech., Ltd. | IZL |
| Oct 5, 2012 | K122697 | PORTA 100HF Job Corporation | IZL |
| Aug 2, 2012 | K121410 | DRAGON LW Sedecal., Sa. | IZL |
| Apr 13, 2012 | K120062 | DRX-REVOLUTION MOBILE X-RAY SYSTEM Carestream Health, Inc. | IZL |
| Sep 19, 2011 | K111912 | MOBILETT MIRA Siemens Medical Solutions USA, Inc. | IZL |
| Aug 5, 2011 | K101517 | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY Sedecal., Sa. | IZL |
| Jul 19, 2011 | K111725 | MOBILEDIAGNOST WDR Sedecal., Sa. | IZL |
| Jun 16, 2011 | K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX Ge Medical Systems, LLC | IZL |
| Jan 26, 2011 | K103522 | SEDECAL Sedecal., Sa. | IZL |
| Jan 3, 2011 | K103597 | DX-D 100 Agfa Healthcare N.V. | IZL |
| Jul 16, 2010 | K092713 | SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM Transamerican Medical Imaging | IZL |
| Apr 23, 2010 | K100449 | MINXRAY MODEL CMDR-2S Minxray, Inc. | IZL |
| Apr 22, 2010 | K100400 | PRESTODR PORTABLE Cmt Medical Technologies, Ltd., IL | IZL |
| Jul 14, 2009 | K090655 | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 Source-Ray, Inc. | IZL |
| Jun 30, 2009 | K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION Shimadzu Corp. | IZL |
| Mar 17, 2009 | K090322 | EASY MOVING PLUS, SM-XXHF-YY Sedecal., Sa. | IZL |
| Nov 21, 2008 | K083048 | NEORAY DR 2520 DIGITAL IMAGING SYSTEM Portavision Medical, LLC | IZL |
| Nov 7, 2008 | K082627 | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL Minxray, Inc. | IZL |
| May 14, 2008 | K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION Shimadzu Corp. | IZL |
| Apr 18, 2008 | K080945 | FCR GO PORTABLE DIGITAL X-RAY SYSTEM Fujifilm Medical Systems U.S.A, Inc. | IZL |
| Sep 25, 2007 | K072392 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZL |
| Jul 11, 2007 | K070634 | SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 Soyee Product, Inc. | IZL |
| May 10, 2007 | K071015 | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZL |
| Dec 26, 2006 | K063262 | AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS Virtual Imaging | IZL |
| Oct 31, 2006 | K062472 | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 Source-Ray, Inc. | IZL |
| Sep 15, 2006 | K061685 | PULSERA Philips Medical Systems North America Co. | IZL |
| Apr 5, 2006 | K060566 | MINXRAY, MODELS HFP24 AND HFP40 Mikasa X-Ray Co., Ltd. | IZL |
| Nov 8, 2005 | K052897 | GE DEFINIUM AMX 700, MODEL AMX 700 General Electric Medical Systems | IZL |
| Oct 27, 2005 | K052721 | MINXRAY, MODEL HF100H+ Minxray, Inc. | IZL |
| Oct 7, 2005 | K052341 | AJEX 9015/135H PORTABLE X-RAY Jpi America, Inc. | IZL |
| Aug 11, 2005 | K052001 | MODEL SR-115 PORTABLE X-RAY SYSTEM Source-Ray, Inc. | IZL |
| Dec 13, 2004 | K043062 | MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM Source-Ray, Inc. | IZL |
| Nov 18, 2004 | K043002 | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR Sedecal., Sa. | IZL |
| Nov 2, 2004 | K042866 | AMX5 AND AMX5D MOBILE X-RAY SYSTEMS Ge Healthcare Technologies | IZL |
| Oct 4, 2004 | K042368 | PRACTIX CONVENIO Philips Medical Systems North America Co. | IZL |
| Sep 29, 2004 | K042361 | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D Sedecal USA, Inc. | IZL |
| Jul 28, 2004 | K041922 | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR General Electric Co. | IZL |
| Jul 13, 2004 | K041763 | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES Shimadzu Corp. | IZL |
| Feb 2, 2004 | K040046 | MINXRAY, MODEL HF120/60H POWERPLUS Minxray, Inc. | IZL |
| Feb 2, 2004 | K032628 | PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF United Radiology Systems, Inc. | IZL |
| Nov 14, 2003 | K033238 | MOBILETTE XP AND MOBILETT XPHYBRID Siemens Medical Systems, Inc. | IZL |
| Sep 10, 2003 | K032280 | SIREMOBIL ISO-C 3D Siemens AG | IZL |
| May 20, 2003 | K030494 | SR-130 Source-Ray, Inc. | IZL |
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