# K192242: Synergy Platform, Synergy, Infinity, VersaHD

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Limited
- Decided: Nov 22, 2019 after 95 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K926449 (1995). 32 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182138: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD, Eleckta Limited (2018) Summary page 5.

## Most influential descendants
- K210500: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (2021), 1 descendant of its own
- K252188: EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (2026), 0 descendants of its own

## Indications for use
Entry-level EMLA (Synergy Platform/Synergy) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body. Mid-level EMLA (Infinity) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT: stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body. High-level EMLA (Versa HD) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT: stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body and for the treatment of functional disorders, such as trigeminal neuralgia.

Source page: https://510kreport.com/device/K192242
Methodology: https://510kreport.com/methodology