System, Image Processing, Radiological
Regulation 892.2050
50510(k)s in 12 months (2,297 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Philips Medical Systems Sales & Service Region No. America Xcelera System, image processing, radiological. Terminated |
LLZ | K022788 |
| Jul 20, 2004 | Siemens Medical Solutions USA, Inc Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163 Terminated |
LLZ | K935694 |
| Nov 6, 2003 | Philips Medical Systems (Cleveland) Inc Philips Odyssey LX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. Terminated |
LLZ | None listed |
| Nov 6, 2003 | Philips Medical Systems (Cleveland) Inc Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. Terminated |
LLZ | None listed |
| Nov 6, 2003 | Philips Medical Systems (Cleveland) Inc Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems. Terminated |
LLZ | K003437 K964712 |
| Sep 12, 2003 | Philips Medical Systems Easy Access PACS System with software Release 5, 6.2, or 7.2 Terminated |
LLZ | K983447 |
| Aug 12, 2003 | Philips Medical Systems EasyWeb Terminated |
LLZ | K982769 |
| Aug 12, 2003 | Philips Medical Systems Easy Access
Software releases 1.1, 5.2, 6.2 & 7.2 Terminated |
LLZ | K983447 |
| Aug 7, 2003 | Siemens Medical Solutions USA, Inc Leonardo Workstations with software versions prior to 2022A Terminated |
LLZ | K010938 |
| Aug 7, 2003 | Siemens Medical Solutions USA, Inc Leonardo Workstations with software version 2022A/B, 2003A Terminated |
LLZ | K010938 |
| Jun 12, 2003 | Fujifilm Medical System USA, Inc. Synapse Version 2.2.1 and 2.3.1 software Terminated |
LLZ | K991257 |
| May 16, 2003 | Siemens Medical Solutions USA, Inc Leonardo MM-WS systems. System, Image Processing. Terminated |
LLZ | K010938 |
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