# Elekta, Ltd.

- Location (FDA's records): Crawley, GB
- FDA decisions: 22 (2005–2021): 22 510(k) clearances
- Names in FDA's records: Elekta , Ltd. (10); Elekta Limited (8); Elekta, Inc. (4)
- Product codes: IYE (19), MUJ (2), IXI (1)
- 510(k) review time since 2016: median 86 days, against 58 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 36 (12 its own); citations of its devices by later devices: 23 (12 its own)
- Recalls linked to its devices: 56 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems, Inc.: 3 (https://510kreport.com/company/philips-medical-systems)
- Varian Medical Systems, Inc.: 3 (https://510kreport.com/company/varian-medical-systems)
- Calypso Medical Technologies, Inc.: 2 (https://510kreport.com/company/calypso-medical-technologies)
- Impac Medical Systems, Inc.: 2 (https://510kreport.com/company/impac-medical-systems)
- Viewray, Incorporated: 2 (https://510kreport.com/company/viewray)
- Math Resolutions, LLC: 2 (https://510kreport.com/company/math-resolutions)
- 3D Line USA, Inc.: 1 (https://510kreport.com/company/3d-line-usa)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)

## Firms that cite its devices most
- Elekta Solutions AB: 4 (https://510kreport.com/company/elekta-solutions)
- Eleckta Limited: 2 (https://510kreport.com/company/eleckta)
- Medphoton GmbH: 1 (https://510kreport.com/company/medphoton)
- Elekta Instrument AB: 1 (https://510kreport.com/company/elekta-instrument)
- RaySearch Laboratories AB (PUBL): 1 (https://510kreport.com/company/raysearch-laboratories-ab-publ)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Hitachi, Ltd. Healthcare: 1 (https://510kreport.com/company/hitachi-healthcare)

## Its most-cited devices
- K131965: XVI R5.0 (2013), cited by 3
- K051932: Elekta Synergy; Elekta Synergy S and XVIR3.5 (2005), cited by 3
- K123808: Agility (2013), cited by 2
- K183034: MOSAIQ Oncology Information System (2018), cited by 2
- K192482: Elekta Unity (2019), cited by 1
- K082122: MLCI2 (2008), cited by 1

## Recent decisions
- K210500: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (Jun 11, 2021)
- K192482: Elekta Unity (Dec 5, 2019)
- K192242: Synergy Platform, Synergy, Infinity, VersaHD (Nov 22, 2019)
- K190178: Monaco RTP System (Mar 29, 2019)
- K183037: Monaco RTP System (Dec 4, 2018)
- K183034: MOSAIQ Oncology Information System (Dec 4, 2018)
- K182076: Elekta Unity (Dec 4, 2018)
- K153011: iViewDose R1.0 (Dec 11, 2015)

Source page: https://510kreport.com/company/elekta