# K982502: Genesis Imrt Linear Accelerator

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 31, 1998 after 11 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882729 (1988). 1 ancestor in all.
28 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882729: Mevatron, M 2 Class, Siemens Medical Laboratories, Inc. (1988) Summary page 1.

## Most influential descendants
- 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
- K082005: Modification to HI-Art Treatment System (2008), 13 descendants of its own

## Recalls of this device
- Dec 19, 2014 · Class II · Z-1059-2015: A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, inc
- May 28, 2014 · Class II · Z-2174-2014: A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment hav
- May 29, 2013 · Class II · Z-1663-2013: The information regarding the FILM Mode calibration may have been considered difficult to interpret when translated. SIEMENS HEALTHCARE CR / RADIATION ONCOLOGY had become aware that this issue may hav
- Nov 4, 2010 · Not classified · Z-2639-2011: 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.

## Indications for use
The GENESIS IMRT Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The GENESIS delivers these treatments conformally, shaping the field of radiation to the tumor volume. The depth of penetration emulating from the GENESIS ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

Source page: https://510kreport.com/device/K982502
Methodology: https://510kreport.com/methodology