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) |
|---|---|---|---|
| Feb 4, 2009 | Medtronic Navigation, Inc Medtronic O-Arm Intraoperative Imaging System
Catalog Number: BI-700-00027 Terminated |
IZL | K050996 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations. Terminated |
IZL | K042368 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations. Terminated |
IZL | K042368 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations. Terminated |
IZL | K042368 |
| May 22, 2007 | GE Medical Systems LLC Definium AMX 700 Digital mobile x-ray system, GE Healthcare 3000 North Grandview Waukesha, WI Terminated |
IZL | K052897 |
| Apr 19, 2007 | Siemens Medical Solutions USA, Inc Mobilett XP, mobile X-ray system, Model number 1818363 Terminated |
IZL | None listed |
| Apr 19, 2007 | Siemens Medical Solutions USA, Inc Mobilett XP, mobile X-ray system, Model number 1818447 Terminated |
IZL | None listed |
| Apr 19, 2007 | Siemens Medical Solutions USA, Inc Mobilett XP, mobile X-ray system, Model number 1818454 Terminated |
IZL | K033238 |
| Oct 19, 2006 | Del Medical Systems Group DynaRad Phantom Portable X-Ray System; Del Medical Imaging Corporation, 11550 West King Street, Franklin Park, IL 60131-1330; Phantom model (PH-150-CM & PH-150-G) Terminated |
IZL | K941363 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Powermobil Mobile X-Ray System Terminated |
IZL | K973598 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Siremobil Iso-C Mobile X-Ray System Terminated |
IZL | K040347 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Siremobil Compact L Mobile X-Ray System Terminated |
IZL | K963093 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Siremobil Compact Mobile X-Ray System Terminated |
IZL | K963093 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Arcadis Orbic Mobile X-Ray System Terminated |
IZL | K040066 |
| Nov 2, 2005 | Siemens Medical Solutions USA, Inc Arcadis Varic Mobile X-Ray System Terminated |
IZL | K042793 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV212 Mobile X-Ray System Terminated |
IZL | K910115 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV29 Mobile X-Ray System Terminated |
IZL | K910115 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV26 Mobile X-Ray System Terminated |
IZL | K921255 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV 25 Gold Mobile X-Ray System Terminated |
IZL | K921255 |
| Sep 15, 2004 | Philips Medical Systems Sales & Service Region No. America BV25 Mobile X-Ray System Terminated |
IZL | K910115 |
| Oct 29, 2003 | Sedecal USA, Inc Sedecal SP-HF 4.0 Portable X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) Spain Terminated |
IZL | K020436 |
| Apr 25, 2003 | Sedecal USA, Inc. Easy Moving Motor Driven Mobile X-Ray Unit, Models SM-20HF and SM-30HF; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN Terminated |
IZL | K012663 |
| Feb 1, 2003 | Philips Medical Systems Philips BV300 Mobile X-Ray System Terminated |
IZL | K953910 |
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