# K882729: Mevatron, M 2 Class

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Laboratories, Inc.
- Decided: Sep 19, 1988 after 75 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 38 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982502: Genesis Imrt Linear Accelerator (1998), 28 descendants of its own
- K013673: HI-Art System (2002), 27 descendants of its own
- K033347: Modification to: HI-Art System (2003), 26 descendants of its own
- K042739: HI-Art System (2004), 25 descendants of its own
- K060912: Modification to: HI-Art System (2006), 24 descendants of its own

## Recalls of this device
- Feb 18, 2020 · Class II · Z-1678-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Feb 18, 2020 · Class II · Z-1679-2020: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
- Jan 25, 2017 · Class II · Z-1436-2017: Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to 
- Dec 1, 2011 · Not classified · Z-0787-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0788-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0796-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0792-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0793-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0783-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0784-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0786-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0789-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0790-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0794-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0798-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0780-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0781-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0785-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0791-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0795-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Dec 1, 2011 · Not classified · Z-0797-2012: Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover.
- Jan 11, 2008 · Not classified · Z-1402-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Jan 11, 2008 · Not classified · Z-1401-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Aug 7, 2007 · Not classified · Z-0683-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Aug 7, 2007 · Not classified · Z-0678-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Aug 7, 2007 · Not classified · Z-0679-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Aug 7, 2007 · Not classified · Z-0682-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Aug 7, 2007 · Not classified · Z-0684-2008: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This prob
- Jul 27, 2007 · Not classified · Z-0852-2008: Door Hinge failures; loose or falling off (Stationary Structure Doors)
- Mar 22, 2007 · Not classified · Z-0156-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0162-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0163-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0155-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0159-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0161-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0157-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0160-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati
- Mar 22, 2007 · Not classified · Z-0158-2008: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to pati

Source page: https://510kreport.com/device/K882729
Methodology: https://510kreport.com/methodology