FDA 510(k) Applications for Medical Device Product Code "IZL"
(System, X-Ray, Mobile)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K103597 | AGFA HEALTHCARE N.V. | DX-D 100 | 01/03/2011 |
| K191884 | Agfa N.V. | DR 100s | 08/09/2019 |
| K122298 | AJEX MEDITECH., LTD | AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR | 03/28/2014 |
| K140723 | ARIBEX, INC. | NOMAD MD 75K V HANDHELD X-RAY SYSTEM | 08/19/2014 |
| K220678 | Aspenstate INC | APX-24 Portable X-ray System | 03/31/2022 |
| K213568 | Carestream Health | DRX-Rise Mobile X-ray System | 03/23/2022 |
| K191025 | Carestream Health Inc. | DRX-Revolution Mobile X-ray System | 05/17/2019 |
| K120062 | CARESTREAM HEALTH, INC. | DRX-REVOLUTION MOBILE X-RAY SYSTEM | 04/13/2012 |
| K170755 | Carestream Health, Inc. | DRX-Revolution Nano Mobile X-ray System | 06/21/2017 |
| K173924 | Carestream Health, Inc. | DRX-Revolution Nano Mobile X-ray System | 02/05/2018 |
| K100400 | CMT MEDICAL TECHNOLOGIES, LTD. | PRESTODR PORTABLE | 04/22/2010 |
| K173018 | Del Medical, Inc. | MDR17 Mobile Direct Radiographic System | 11/20/2017 |
| K143494 | DEXCOWIN CO., LTD | ADX6000 Portable X-Ray System; iRayA6 | 10/05/2015 |
| K183388 | DRGEM Corporation | JADE Mobile X-Ray | 02/05/2019 |
| K183292 | DRGEM Corporation | Topaz Mobile DR System | 05/15/2019 |
| K201124 | DRGEM Corporation | TOPAZ Mobile DR System | 05/19/2020 |
| K973833 | DYNARAD CORP. | CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL | 12/30/1997 |
| K151038 | ECOTRON CO.,LTD | EPX-Series Mobile X-ray System | 07/24/2015 |
| K972365 | EUROTEC, S.R.L. | COMPACT OR COMP-X | 12/12/1997 |
| K221081 | First Source Inc. | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | 06/13/2022 |
| K080945 | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. | FCR GO PORTABLE DIGITAL X-RAY SYSTEM | 04/18/2008 |
| K170858 | FUJIFILM Medical Systems U.S.A., Inc. | FDR AQRO (DR-XD 1000) | 04/24/2017 |
| K042866 | GE HEALTHCARE TECHNOLOGIES | AMX5 AND AMX5D MOBILE X-RAY SYSTEMS | 11/02/2004 |
| K021016 | GE MEDICAL SYSTEMS | AMX-4 PLUS MOBILE X-RAY SYSTEM | 06/17/2002 |
| K210982 | GE Medical Systems, LLC | AMX Navigate | 04/28/2021 |
| K103476 | GE MEDICAL SYSTEMS, LLC | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | 06/16/2011 |
| K142383 | GE Medical Systems, LLC | Optima XR200amx, Optima XR220amx | 09/25/2014 |
| K162990 | GE Medical Systems, LLC | Optima XR240amx | 11/15/2016 |
| K182234 | GE Medical Systems, LLC | Optima XR240amx | 09/06/2018 |
| K173602 | GE Medical Systems, LLC | Optima XR240amx, AutoGrid | 01/12/2018 |
| K041922 | GENERAL ELECTRIC CO. | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR | 07/28/2004 |
| K052897 | GENERAL ELECTRIC MEDICAL SYSTEMS | GE DEFINIUM AMX 700, MODEL AMX 700 | 11/08/2005 |
| K213405 | HDT Co., Ltd | MINE ALNU (Model: Mine 2.1) | 07/10/2022 |
| K143537 | HITACHI MEDICAL SYSTEMS AMERICA, INC. | Sirius Starmobile tiara | 03/06/2015 |
| K181874 | Huestis Machine Corporation | MX40 Mobile Digital X-ray System | 09/14/2018 |
| K981466 | IMAGING SCIENCES INTL., INC. | XR-910 | 07/14/1998 |
| K010304 | IROM IMAGING, INC. | MXR-2000 MOBILE X-RAY UNIT | 02/12/2001 |
| K122697 | JOB CORPORATION | PORTA 100HF | 10/05/2012 |
| K052341 | JPI AMERICA, INC. | AJEX 9015/135H PORTABLE X-RAY | 10/07/2005 |
| K141539 | KUB TECHNOLOGIES, INC | KUBTEC X250 | 10/29/2014 |
| K193535 | Livermoretech Inc. | EZER, Portable X-ray System | 05/07/2020 |
| K002685 | MEDISON RADIOLOGY SYSTEMS, INC. | CORDLESS COMPACT MOBILE X-RAY SYSTEM | 09/15/2000 |
| K162687 | MERIDIAN MEDICAL SYSTEMS, LLC | Paragon 2 | 10/21/2016 |
| K211423 | Micro-X Limited | Rover | 05/21/2021 |
| K201488 | Micro-X Ltd. | Rover | 07/17/2020 |
| K060566 | MIKASA X-RAY CO., LTD. | MINXRAY, MODELS HFP24 AND HFP40 | 04/05/2006 |
| K201575 | MinXray, Inc | CMDR 2C (Multiple Models) | 07/08/2020 |
| K191451 | MinXray, Inc | CMDR 2CW (Multiple models) | 07/03/2019 |
| K182207 | MinXray, Inc | TR90BH | 12/14/2018 |
| K171353 | MinXray, Inc. | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris | 06/07/2017 |
| K141885 | MINXRAY, INC. | CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY | 09/18/2014 |
| K153059 | MINXRAY, INC. | HF1202H PowerPlus Portable X-ray Equipment | 02/02/2016 |
| K210479 | MinXray, Inc. | IMPACT and X-Ranger | 03/19/2021 |
| K973712 | MINXRAY, INC. | MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT | 12/12/1997 |
| K100449 | MINXRAY, INC. | MINXRAY MODEL CMDR-2S | 04/23/2010 |
| K082627 | MINXRAY, INC. | MINXRAY, MODEL CMDR-1S AND CMDR-1S-MIL | 11/07/2008 |
| K052721 | MINXRAY, INC. | MINXRAY, MODEL HF100H+ | 10/27/2005 |
| K040046 | MINXRAY, INC. | MINXRAY, MODEL HF120/60H POWERPLUS | 02/02/2004 |
| K212134 | Nanjing Perlove Medical Equipment Co., Ltd. | Diagnostic X-ray System/PLX5200A | 08/25/2021 |
| K203782 | Nano-x Imaging Ltd. | Nanox Cart X-ray System | 04/01/2021 |
| K211383 | NEUF Inc. | NFLK-2501 Portable X-ray Unit | 08/13/2021 |
| K230581 | NEUF Inc. | TOPA12 Portable X-ray Unit | 08/16/2023 |
| K182317 | OEHM UND REHBEIN GMBH | AMADEO M-DR mini, AMADEO M-AX mini | 09/24/2018 |
| K203658 | OXOS Medical, Inc. | Micro C Medical Imaging System, M01 | 01/12/2021 |
| K211473 | OXOS Medical, Inc. | Micro C Medical Imaging System, M01 | 06/04/2021 |
| K212654 | OXOS Medical, Inc. | Micro C Medical Imaging System, M01 | 02/04/2022 |
| K173187 | Philips India Limited | MobileDiagnost M50 | 11/16/2017 |
| K042368 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | PRACTIX CONVENIO | 10/04/2004 |
| K061685 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | PULSERA | 09/15/2006 |
| K970234 | PORTABLE POWER SYSTEMS, INC. | SEALED LEAD ACID BATTERY PACK | 05/02/1997 |
| K083048 | PORTAVISION MEDICAL LLC | NEORAY DR 2520 DIGITAL IMAGING SYSTEM | 11/21/2008 |
| K222896 | POSKOM Co.,Ltd. | AirRay | 12/20/2022 |
| K200726 | Radmedix LLC | AcuityPDR | 04/13/2020 |
| K212144 | Remedi Co. Ltd. | Remex KA6 | 08/03/2021 |
| K220175 | Samsung Electronics Co. Ltd. | GM85 | 04/21/2022 |
| K162278 | SAMSUNG ELECTRONICS CO., LTD. | Digital Diagnostic Mobile X-ray System | 11/15/2016 |
| K181626 | Samsung Electronics Co., Ltd. | Digital Diagnostic Mobile X-ray System | 07/20/2018 |
| K150097 | SAMSUNG ELECTRONICS CO., LTD. | GM60A-32S & GM60A-40S | 02/19/2015 |
| K142492 | SAMSUNG ELECTRONICS CO., LTD. | GM60A-32S, GM60A-40S | 12/17/2014 |
| K222353 | Samsung Electronics Co., LTD. | GM85 | 09/29/2022 |
| K171119 | Samsung Electronics Co.,Ltd. | GM85 | 05/12/2017 |
| K090322 | SEDECAL S.A. | EASY MOVING PLUS, SM-XXHF-YY | 03/17/2009 |
| K020436 | SEDECAL S.A. | PORTABLE X-RAY UNITS; MODELS SP-HF-2.8 & SP-HF-4.0 | 02/22/2002 |
| K103522 | SEDECAL S.A. | SEDECAL | 01/26/2011 |
| K101517 | SEDECAL S.A. | SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY | 08/05/2011 |
| K043002 | SEDECAL S.A. | SEDECAL MOBILE X-RAY UNITS WITH DIGITAL DETECTOR | 11/18/2004 |
| K121410 | SEDECAL SA | DRAGON LW | 08/02/2012 |
| K173299 | Sedecal SA | DRAGON X SPSL4HC, DRAGON X SPSL8HC | 01/26/2018 |
| K111725 | SEDECAL SA | MOBILEDIAGNOST WDR | 07/19/2011 |
| K141895 | SEDECAL SA | MOBILEDIAGNOST WDR | 09/18/2014 |
| K191813 | Sedecal SA | MobileDiagnost wDR 2.2 | 08/02/2019 |
| K212291 | Sedecal SA | PHOENIX | 09/14/2021 |
| K221803 | SEDECAL SA | PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. | 07/18/2022 |
| K161345 | SEDECAL SA | RadPRO« Mobile 40kW; RadPRO« Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR | 07/06/2016 |
| K232185 | Sedecal SA | SM-IV | 08/21/2023 |
| K222951 | SEDECAL SA | SM-V | 11/21/2022 |
| K042361 | SEDECAL USA, INC. | DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D | 09/29/2004 |
| K012663 | SEDECAL USA, INC. | EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) | 08/31/2001 |
| K192011 | Sedecal, SA. | PhoeniX | 09/25/2019 |
| K192936 | Sedecal., SA. | Soltus 500 | 11/15/2019 |
| K222339 | Shanghai United Imaging Healthcare Co., Ltd. | uDR 380i Pro | 09/30/2022 |
| K202350 | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System | 01/06/2021 |
| K202353 | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System | 12/23/2020 |
| K200637 | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) | SR-8100 Portable X-ray Unit | 07/09/2020 |
| K200976 | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) | SR-8230, SR-8230S Portable X-ray Unit | 06/10/2020 |
| K090268 | SHIMADZU CORP. | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | 06/30/2009 |
| K080701 | SHIMADZU CORP. | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | 05/14/2008 |
| K001517 | SHIMADZU CORP. | SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES | 06/27/2000 |
| K041763 | SHIMADZU CORP. | SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES | 07/13/2004 |
| K032280 | SIEMENS AG | SIREMOBIL ISO-C 3D | 09/10/2003 |
| K231577 | Siemens Medical Solutions | MOBILETT Impact | 07/25/2023 |
| K022337 | SIEMENS MEDICAL SOLUTIONS USA, INC. | 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D | 08/13/2002 |
| K111912 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MOBILETT MIRA | 09/19/2011 |
| K071015 | SIEMENS MEDICAL SOLUTIONS USA, INC. | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | 05/10/2007 |
| K072392 | SIEMENS MEDICAL SOLUTIONS USA, INC. | OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM | 09/25/2007 |
| K182639 | Siemens Medical Solutions, Inc. | MOBILETT Elara Max | 03/15/2019 |
| K033238 | SIEMENS MEDICAL SYSTEMS, INC. | MOBILETTE XP AND MOBILETT XPHYBRID | 11/14/2003 |
| K212940 | Skanray Technologies Limited | Skanmobile, Skanmobile-Dr | 03/04/2022 |
| K170607 | Solutions For Tomorrow AB | !M1 | 07/17/2017 |
| K052001 | SOURCE-RAY, INC. | MODEL SR-115 PORTABLE X-RAY SYSTEM | 08/11/2005 |
| K043062 | SOURCE-RAY, INC. | MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM | 12/13/2004 |
| K062472 | SOURCE-RAY, INC. | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 | 10/31/2006 |
| K090655 | SOURCE-RAY, INC. | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 | 07/14/2009 |
| K030494 | SOURCE-RAY, INC. | SR-130 | 05/20/2003 |
| K163063 | SOURCE-RAY, INC. | UC-5000 Mobile X-Ray | 12/12/2016 |
| K070634 | SOYEE PRODUCT, INC. | SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110 | 07/11/2007 |
| K212515 | Stephanix | MOVIX DReamy | 11/03/2021 |
| K972204 | STERNE EQUIPMENT CO., LTD. | ACU-RAY HF SERIES PORTABLE X-RAY UNIT | 10/08/1997 |
| K222258 | Suzhou Powersite Electric Co., Ltd. | Combined High Frequency X-ray Source | 11/01/2022 |
| K092713 | TRANSAMERICAN MEDICAL IMAGING | SPECTRE WIRELESS ENCRYPTED FOOTSWITCH AND HAND SWITCH SYSTEM | 07/16/2010 |
| K012379 | TREX ENTERPRISES CORP. | PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM | 08/16/2001 |
| K992229 | TREX MEDICAL CORP. | MXU-125 OR TMX-125 | 08/06/1999 |
| K032628 | UNITED RADIOLOGY SYSTEMS, INC. | PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF | 02/02/2004 |
| K203667 | Vatech Co., Ltd | EzRay M (Model: VMX-P300) | 02/02/2021 |
| K213462 | Vatech Co., Ltd | EzRay M18 (Model: VMX-P400) | 02/11/2022 |
| K063262 | VIRTUAL IMAGING | AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS | 12/26/2006 |
| K201340 | VMI Tecnologias LTDA | AQUILA 320 D / AQUILA 320 S | 06/19/2020 |
| K221417 | VSI Co., Ltd. | CLAROX plus (Model: VX-100) | 09/13/2022 |
| K220700 | Yian Medical Technology (Haining) Co., Ltd | Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine | 05/04/2022 |
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