Block, Beam-shaping, Radiation Therapy
Radiology · 21 CFR 892.5710
Recent MDR events
38 adverse event reports on file
- .DECIMAL RANGE COMPENSATOROct 19, 2016Malfunction.decimal3007087027-2016-00002
- APEXMar 14, 2014MalfunctionElekta Ltd9617016-2014-00006
- BEAM MODULATOROct 2, 2013MalfunctionElekta Limited9617016-2013-00014
- DMLC IVApr 23, 2013OtherElekta Ltd.9617016-2013-00005
- APEXNov 28, 2012Elekta Ltd.9617016-2012-00008
- APEXNov 22, 2012Elekta Ltd.9617016-2012-00007
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMMay 23, 2012OtherXoft, Inc.3005594788-2012-00001
- AXXENT FLEXISHIELD MINIJul 8, 2011MalfunctionXoft, Inc.3005594788-2011-00027
- AXXENT FLEXISHIELD MINIJul 8, 2011MalfunctionXoft, Inc.3005594788-2011-00028
- AXXENT FLEXISHIELD MINIJun 16, 2011MalfunctionXoft, Inc.3005594788-2011-00024
Event type breakdown
Recalls
6 recall events for this product code
- Elekta, Inc.TerminatedFeb 25, 2014
DMLC IV-ERGO
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Z-0978-2014 · View FDA record ↗ - Elekta, Inc.TerminatedSep 4, 2013
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Z-2157-2013 · View FDA record ↗ - Elekta, Inc.TerminatedFeb 26, 2013
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Z-0885-2013 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedMar 7, 2012
Siemens mMLC (ModuLeaf) safety bar and trolley label.
This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard.
Z-1184-2012 · View FDA record ↗ - Xoft Inc.TerminatedApr 1, 2011
Axxent Flexishield Mini
Xoft Axxent Flexishield Mini product may may shed particles identified as tungsten, and may look like suspicious calcifications on follow up scans if the product was used during Intraoperative radiation therapy.
Z-1865-2011 · View FDA record ↗ - Philips Medical Systems North America Co. PhillipsTerminatedSep 1, 2008
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.
Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
Z-1642-2008 · View FDA record ↗
Registered firms
21 firms currently registered for this product code
Vha Office Of Advanced Manufacturing - Ft. Lawton
Seattle, WA, US
Cq Decimal, Llc
Sanford, FL, US
Aktina Medical Corp.
Congers, NY, US
Anatomical Geometry S.l.
MAIRENA DEL ALJARAFE Sevilla, ES
Myrava, Inc.
Indianapolis, IN, US
Huestis Machine Corp.
Bristol, RI, US
Medical Modeling - A 3d Systems Company
Littleton, CO, US
Myrava, Inc.
Parma, OH, US
Elekta Inc.
San Jose, CA, US
Siemens Healthineers Ag Varian Cancer Therapy (cth)
Erlangen Bavaria, DE
Elekta Solutions Ab
STOCKHOLM, SE
Myrava, Inc.
Winston Salem, NC, US
510(k) clearances
51 clearances for this product code
- Ricoh 3D For Healthcare, LLCApr 6, 2026
K253025 · Ricoh 3D for Healthcare Bolus
- Vha DeanNov 4, 2022
K222639 · VHA Radiotherapy Bolus
- 3D SystemsMar 30, 2022
K214093 · VSP Bolus
- .Decimal, Inc.Oct 16, 2013
K132236 · .DECIMAL PROTON APERTURE
- Cura Medical Technologies, LLCJul 30, 2013
K131150 · CURA COMPENSATOR
- Cura Medical Technologies, LLCMar 4, 2013
K123893 · CURA COLLIMATOR
- .Decimal, Inc.Nov 21, 2012
K123015 · .DECIMAL PHOTON BLOCK
- Elekta LimitedSep 30, 2011
K111676 · APEX