Block, Beam-Shaping, Radiation Therapy
Regulation 892.5710
1510(k)s in 12 months (51 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in IXI
| Company | 510(k)s | Recalls |
|---|---|---|
| .Decimal, Inc. | 6 | 0 |
| Siemens Medical Solutions USA, Inc. | 5 | 1 |
| Elekta Limited | 1 | 3 |
| Aktina Medical Physics Corp. | 2 | 0 |
| Cura Medical Technologies, LLC | 2 | 0 |
| Huestis Machine Corp. | 2 | 0 |
| Med-Tec,Inc. | 2 | 0 |
| Medtec, Inc. | 2 | 0 |
| Mrc Systems GmbH | 2 | 0 |
| Xoft, Inc. | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | Elekta, Inc. DMLC IV-ERGO
Product Usage:
Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so Terminated |
IXI | K001163 |
| Sep 4, 2013 | Elekta, Inc. DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Terminated |
IXI | K001163 |
| Feb 26, 2013 | Elekta, Inc. Elekta, Apex add-on Micro MLC, collimator for radiation therapy. Terminated |
IXI | K111676 |
| Mar 7, 2012 | Siemens Medical Solutions USA, Inc Siemens mMLC (ModuLeaf) safety bar and trolley label.
Siemens Medical Solutions USA, Inc.
Concord, CA.
The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator s Terminated |
IXI | K030609 |
| Apr 1, 2011 | Xoft Inc. Axxent Flexishield Mini
To shape the beam from a low energy radiation therapy source up to 50kVp. Terminated |
IXI | K090417 |
| Sep 1, 2008 | Philips Medical Systems North America Co. Phillips AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option. Terminated |
IXI | K041949 |
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