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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2015 | Sedecal USA, Inc. Sedecal SA Mobile Diagnost w DR x-ray system Terminated |
IZL | K111725 |
| Feb 9, 2015 | Virtual Imaging, Inc. Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients. Terminated |
IZL | K101517 |
| Feb 2, 2015 | Sedecal S.A. MobileDiagnost wDR motorized portable diagnostic X-ray systems. Terminated |
IZL | K111725 |
| Dec 16, 2014 | Carestream 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 |
IZL | K120062 |
| Dec 16, 2014 | Philips 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 |
IZL | K111725 |
| Aug 10, 2014 | AGFA 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 |
IZL | K103597 |
| Jul 21, 2014 | AGFA 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 |
IZL | K103597 |
| Jul 2, 2014 | Siemens 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 |
IZL | K033238 |
| Mar 7, 2014 | Shimadzu 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 |
IZL | K001517 |
| Jan 21, 2014 | Carestream 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 |
IZL | K051258 |
| Jan 21, 2014 | Carestream 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 |
IZL | K091889 |
| Jan 21, 2014 | Carestream 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 |
IZL | K091889 |
| Jan 11, 2014 | GE Healthcare, LLC GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5, 5555000-6, and 5421698. Terminated |
IZL | K103476 |
| Jan 3, 2014 | Carestream 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 |
IZL | None listed |
| Jan 3, 2014 | Trans 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 |
IZL | K092713 |
| Nov 7, 2013 | Carestream 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 |
IZL | K120062 |
| Nov 1, 2013 | Carestream 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 |
IZL | K120062 |
| Oct 31, 2013 | Carestream 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 |
IZL | K120062 |
| Oct 31, 2013 | Carestream Health, Inc. Carestream DRX-Revolution Mobile X-ray System.
Produces radiographic images. Terminated |
IZL | K120062 |
| Aug 21, 2013 | Philips 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 |
IZL | K111725 |
| Aug 9, 2013 | GE 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 |
IZL | K103476 |
| Aug 5, 2013 | Siemens Medical Solutions USA, Inc Mobiletta Mira
Mobile X-ray System Terminated |
IZL | K111912 |
| Jun 6, 2013 | AGFA 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 |
IZL | K103597 |
| Jun 3, 2013 | Shimadzu 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 |
IZL | K080701 |
| Apr 10, 2013 | GE 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 |
IZL | K910902 |
| Dec 6, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilette Mira, intended use as Mobile x-ray system. Terminated |
IZL | K111912 |
| Nov 29, 2012 | GE 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 |
IZL | None listed |
| Nov 29, 2012 | GE 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 |
IZL | None listed |
| Nov 29, 2012 | GE 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 |
IZL | None listed |
| Nov 28, 2012 | Philips Healthcare Inc. Mobile Diagnostic X-Ray System with Digital Panel Terminated |
IZL | K111725 |
| Nov 8, 2012 | Shimadzu 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 |
IZL | K080701 |
| Nov 8, 2012 | Shimadzu 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 |
IZL | K090268 |
| Nov 8, 2012 | Shimadzu 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 |
IZL | K041763 |
| Nov 8, 2012 | Shimadzu 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 |
IZL | K001517 |
| Sep 13, 2012 | GE Healthcare, LLC Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body. Terminated |
IZL | None listed |
| Sep 13, 2012 | GE Healthcare, LLC Optima XR220amx Mobile general purpose radiographic imaging of the human head and body. Terminated |
IZL | None listed |
| Sep 11, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilett Mira mobile x-ray system
Product Usage:
Mobile x-ray system Terminated |
IZL | K111912 |
| Sep 6, 2012 | Siemens Medical Solutions USA, Inc Siemens Mobilett Mira.
Mobile X-Ray System. Terminated |
IZL | K111912 |
| Aug 1, 2012 | GE 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 |
IZL | K992506 |
| Aug 1, 2012 | GE 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 |
IZL | K021049 |
| Jul 19, 2012 | GE 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 |
IZL | None listed |
| Jun 21, 2012 | Medtronic 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 |
IZL | K092564 |
| Jun 13, 2012 | Philips Healthcare Inc. Philips Healthcare Practix Convenio Mobile X-ray system
Worldwide Distribution -- Nationwide Terminated |
IZL | None listed |
| May 30, 2012 | Philips 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 |
IZL | K042368 |
| Apr 24, 2012 | GE 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 |
IZL | None listed |
| Aug 11, 2011 | Siemens Medical Solutions USA, Inc Siemens Axiom Artis U mobile x-ray system
Product Usage: Mobile x-ray system Terminated |
IZL | K040675 |
| Mar 8, 2011 | Philips 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 |
IZL | K010762 |
| Dec 17, 2010 | Siemens Medical Solutions USA, Inc Mobilett XP Hybrid/Digital/CR
Intended use: mobile x-ray system Terminated |
IZL | K033238 |
| Nov 23, 2010 | Medtronic 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 |
IZL | K092564 |
| Nov 1, 2010 | Siemens Medical Solutions USA, Inc Mobilett XP and Mobilett XP Hybrid, Mobile radiology device
System, x-ray, mobile Terminated |
IZL | K033238 |
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