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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)
5recalls in 12 months (173 all time)
161recalls that name a 510(k)
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Top companies in IZL

DateFirm and productCodeLinked 510(k)
Mar 23, 2015Sedecal USA, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
Terminated
IZLK111725
Feb 9, 2015Virtual Imaging, Inc.
Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
Terminated
IZLK101517
Feb 2, 2015Sedecal S.A.
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Terminated
IZLK111725
Dec 16, 2014Carestream Health Inc
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray Syst
Terminated
IZLK120062
Dec 16, 2014Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric p
Terminated
IZLK111725
Aug 10, 2014AGFA Healthcare Corp.
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Terminated
IZLK103597
Jul 21, 2014AGFA Corp.
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image
Terminated
IZLK103597
Jul 2, 2014Siemens Medical Solutions USA, Inc
Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards,
Terminated
IZLK033238
Mar 7, 2014Shimadzu Medical Systems
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatient
Terminated
IZLK001517
Jan 21, 2014Carestream Health, Inc.
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimat
Terminated
IZLK051258
Jan 21, 2014Carestream Health, Inc.
DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a c
Terminated
IZLK091889
Jan 21, 2014Carestream Health, Inc.
DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a co
Terminated
IZLK091889
Jan 11, 2014GE Healthcare, LLC
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698.
Terminated
IZLK103476
Jan 3, 2014Carestream Health Inc.
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray sys
Terminated
IZLNone listed
Jan 3, 2014Trans American Medical, Inc.
Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The Spectre Wireless Encrypted Footswitch/Hand Switch System is a prescription use system and intended only for use wi
Terminated
IZLK092713
Nov 7, 2013Carestream Health Inc.
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatri
Terminated
IZLK120062
Nov 1, 2013Carestream Health Inc.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on
Terminated
IZLK120062
Oct 31, 2013Carestream Health, Inc.
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed t
Terminated
IZLK120062
Oct 31, 2013Carestream Health, Inc.
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images.
Terminated
IZLK120062
Aug 21, 2013Philips Healthcare Inc.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qual
Terminated
IZLK111725
Aug 9, 2013GE Healthcare, LLC
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and proc
Terminated
IZLK103476
Aug 5, 2013Siemens Medical Solutions USA, Inc
Mobiletta Mira Mobile X-ray System
Terminated
IZLK111912
Jun 6, 2013AGFA Corp.
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image
Terminated
IZLK103597
Jun 3, 2013Shimadzu Medical Systems
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency
Terminated
IZLK080701
Apr 10, 2013GE Healthcare, LLC
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage:
Terminated
IZLK910902
Dec 6, 2012Siemens Medical Solutions USA, Inc
Siemens Mobilette Mira, intended use as Mobile x-ray system.
Terminated
IZLK111912
Nov 29, 2012GE Healthcare, LLC
GE Healthcare Optima XR 200 amx with Digital Upgrade. The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or com
Terminated
IZLNone listed
Nov 29, 2012GE Healthcare, LLC
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or c
Terminated
IZLNone listed
Nov 29, 2012GE Healthcare, LLC
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or c
Terminated
IZLNone listed
Nov 28, 2012Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
Terminated
IZLK111725
Nov 8, 2012Shimadzu Medical Systems
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Terminated
IZLK080701
Nov 8, 2012Shimadzu Medical Systems
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Terminated
IZLK090268
Nov 8, 2012Shimadzu Medical Systems
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the
Terminated
IZLK041763
Nov 8, 2012Shimadzu Medical Systems
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The de
Terminated
IZLK001517
Sep 13, 2012GE Healthcare, LLC
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Terminated
IZLNone listed
Sep 13, 2012GE Healthcare, LLC
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Terminated
IZLNone listed
Sep 11, 2012Siemens Medical Solutions USA, Inc
Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
Terminated
IZLK111912
Sep 6, 2012Siemens Medical Solutions USA, Inc
Siemens Mobilett Mira. Mobile X-Ray System.
Terminated
IZLK111912
Aug 1, 2012GE OEC Medical Systems, Inc
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including
Terminated
IZLK992506
Aug 1, 2012GE OEC Medical Systems, Inc
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinica
Terminated
IZLK021049
Jul 19, 2012GE Healthcare, LLC
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Terminated
IZLNone listed
Jun 21, 2012Medtronic Navigation, Inc.
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and
Terminated
IZLK092564
Jun 13, 2012Philips Healthcare Inc.
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Terminated
IZLNone listed
May 30, 2012Philips Healthcare Inc.
Philips Practix Convenio Mobile X-ray System Model: 70455 The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical di
Terminated
IZLK042368
Apr 24, 2012GE Healthcare, LLC
GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI
Terminated
IZLNone listed
Aug 11, 2011Siemens Medical Solutions USA, Inc
Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system
Terminated
IZLK040675
Mar 8, 2011Philips Medical Systems North America Co. Phillips
Philips BV Libra, Mobile X-ray unit, 718022. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety surgical and non-surgical applications including; cerebral,
Terminated
IZLK010762
Dec 17, 2010Siemens Medical Solutions USA, Inc
Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
Terminated
IZLK033238
Nov 23, 2010Medtronic Navigation, Inc.
Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006) used in Product Catalog Numbers: 9732719,9733346,81-700-00027, 81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-0002
Terminated
IZLK092564
Nov 1, 2010Siemens Medical Solutions USA, Inc
Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile
Terminated
IZLK033238

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