# K182138: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD

- Pathway: 510(k) (Traditional)
- Applicant: Eleckta Limited
- Decided: Sep 5, 2018 after 29 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: 8 generations back to K926449 (1995). 31 ancestors in all.
3 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)
- K123808: Agility, Elekta, Ltd. (2013) Summary page 4.
- K051932: Elekta Synergy; Elekta Synergy S and XVIR3.5, Elekta, Inc. (2005) Summary page 4.

## Most influential descendants
- K192242: Synergy Platform, Synergy, Infinity, VersaHD (2019), 2 descendants of its own
- 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
The Elekta Medical Linear Accelerator is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation for treatment that includes but is not limited to, malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

Source page: https://510kreport.com/device/K182138
Methodology: https://510kreport.com/methodology