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Panels › Radiology › Product code IZL · Class 2

System, X-Ray, Mobile

Regulation 892.1720

7510(k)s in 12 months (238 all time)
6recalls in 12 months (173 all time)
161recalls that name a 510(k)
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Top companies in IZL

Company510(k)sRecalls
Sedecal USA, Inc.1958
Siemens Medical Solutions618
Carestream Health713
GE Medical Systems810
Minxray, Inc.150
GE Healthcare014
Micro-X , Ltd.210
General X-Ray, Inc.110
Shimadzu Medical Systems18
Samsung Electronics Co., Ltd.80
Decided510(k)Device and applicantCode
Jun 4, 2021K211473Micro C Medical Imaging System, M01
Oxos Medical, Inc.
IZL
May 21, 2021K211423Rover
Micro-X Limited, AU
IZL
Apr 28, 2021K210982AMX Navigate
Ge Medical Systems, LLC
IZL
Apr 1, 2021K203782Nanox Cart X-ray System
Nano-X Imaging , Ltd., IL
IZL
Mar 19, 2021K210479IMPACT and X-Ranger
Minxray, Inc.
IZL
Feb 2, 2021K203667EzRay M (Model: VMX-P300)
VATECH Co., Ltd., KR
IZL
Jan 12, 2021K203658Micro C Medical Imaging System, M01
Oxos Medical, Inc.
IZL
Jan 6, 2021K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IZL
Dec 23, 2020K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IZL
Jul 17, 2020K201488Rover
Micro-X , Ltd., AU
IZL
Jul 9, 2020K200637SR-8100 Portable X-ray Unit
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IZL
Jul 8, 2020K201575CMDR 2C (Multiple Models)
Minxray, Inc.
IZL
Jun 19, 2020K201340AQUILA 320 D / AQUILA 320 S
Vmi Tecnologias Ltda, BR
IZL
Jun 10, 2020K200976SR-8230, SR-8230S Portable X-ray Unit
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IZL
May 19, 2020K201124TOPAZ Mobile DR System
DRGEM Corporation, KR
IZL
May 7, 2020K193535EZER, Portable X-ray System
Livermoretech, Inc.
IZL
Apr 13, 2020K200726AcuityPDR
Radmedix, LLC
IZL
Nov 15, 2019K192936Soltus 500
Sedecal., Sa., ES
IZL
Sep 25, 2019K192011PhoeniX
Sedecal., Sa., ES
IZL
Aug 9, 2019K191884DR 100s
Agfa N.V., BE
IZL
Aug 2, 2019K191813MobileDiagnost wDR 2.2
Sedecal., Sa., ES
IZL
Jul 3, 2019K191451CMDR 2CW (Multiple models)
Minxray, Inc.
IZL
May 17, 2019K191025DRX-Revolution Mobile X-ray System
Carestream Health, Inc.
IZL
May 15, 2019K183292Topaz Mobile DR System
DRGEM Corporation, KR
IZL
Mar 15, 2019K182639MOBILETT Elara Max
Siemens Medi Cal Solutions, Inc.
IZL
Feb 5, 2019K183388JADE Mobile X-Ray
DRGEM Corporation, KR
IZL
Dec 14, 2018K182207TR90BH
Minxray, Inc.
IZL
Sep 24, 2018K182317AMADEO M-DR mini, AMADEO M-AX mini
Oehm Und Rehbein GmbH, DE
IZL
Sep 14, 2018K181874MX40 Mobile Digital X-ray System
Huestis Machine Corporation
IZL
Sep 6, 2018K182234Optima XR240amx
Ge Medical Systems, LLC
IZL
Jul 20, 2018K181626Digital Diagnostic Mobile X-ray System
Samsung Electronics Co., Ltd., KR
IZL
Feb 5, 2018K173924DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc.
IZL
Jan 26, 2018K173299DRAGON X SPSL4HC, DRAGON X SPSL8HC
Sedecal., Sa., ES
IZL
Jan 12, 2018K173602Optima XR240amx, AutoGrid
Ge Medical Systems, LLC
IZL
Nov 20, 2017K173018MDR17 Mobile Direct Radiographic System
Del Medical, Inc.
IZL
Nov 16, 2017K173187MobileDiagnost M50
Philips India Limited, IN
IZL
Jul 17, 2017K170607!M1
Solutions For Tomorrow AB, SE
IZL
Jun 21, 2017K170755DRX-Revolution Nano Mobile X-ray System
Carestream Health, Inc.
IZL
Jun 7, 2017K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
Minxray, Inc.
IZL
May 12, 2017K171119GM85
Samsung Electronics Co., Ltd., KR
IZL
Apr 24, 2017K170858FDR AQRO (DR-XD 1000)
Fujifilm Medical Systems U.S.A, Inc.
IZL
Dec 12, 2016K163063UC-5000 Mobile X-Ray
Source-Ray, Inc.
IZL
Nov 15, 2016K162990Optima XR240amx
Ge Medical Systems, LLC
IZL
Nov 15, 2016K162278Digital Diagnostic Mobile X-ray System
Samsung Electronics Co., Ltd., KR
IZL
Oct 21, 2016K162687Paragon 2
Meridian Medical Systems, LLC
IZL
Jul 6, 2016K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
Sedecal., Sa., ES
IZL
Feb 2, 2016K153059HF1202H PowerPlus Portable X-ray Equipment
Minxray, Inc.
IZL
Oct 5, 2015K143494ADX6000 Portable X-Ray System; iRayA6
Dexcowin Co., Ltd., KR
IZL
Jul 24, 2015K151038EPX-Series Mobile X-ray System
Ecotron Co., Ltd., KR
IZL
Mar 6, 2015K143537Sirius Starmobile tiara
Hitachi Medical Systems America, Inc.
IZL

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