# K862339: Mevatron KD-2

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Laboratories, Inc.
- Decided: Oct 29, 1986 after 131 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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
- K031764: Oncor Avant-Garde with Coherence Workspaces (2003), 16 descendants of its own
- K060226: Oncor Expression (2006), 13 descendants of its own
- K072485: Artiste MV SA (2007), 11 descendants of its own
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own

## Recalls of this device
- Jan 25, 2017 · Class II · Z-1437-2017: 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 
- Nov 4, 2010 · Not classified · Z-2636-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Nov 4, 2010 · Not classified · Z-2638-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Nov 4, 2010 · Not classified · Z-2637-2011: The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.
- Jan 11, 2008 · Not classified · Z-1395-2008: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Dec 10, 2007 · Not classified · Z-1758-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1755-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1753-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1756-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1757-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Dec 10, 2007 · Not classified · Z-1754-2008: Radiation leak: When used with field sizes of 5cm x 5cm or smaller, product may leak radiation at a distance 2 cm from the side of the applicator body up to 13%, in excess of IEC standards.
- Aug 7, 2007 · Not classified · Z-0680-2008: 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-0677-2008: 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-0681-2008: 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-0685-2008: 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-0851-2008: Door Hinge failures; loose or falling off (Stationary Structure Doors)

Source page: https://510kreport.com/device/K862339
Methodology: https://510kreport.com/methodology