# Elekta Instrument AB

- Location (FDA's records): Stockholm, SE
- FDA decisions: 35 (1996–2019): 35 510(k) clearances
- Product codes: HAW (16), IWB (13), MUJ (4), IYE (2)
- 510(k) review time since 2016: median 119 days, against 147 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 55 (29 its own); citations of its devices by later devices: 49 (29 its own)
- Recalls linked to its devices: 24 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Patterson Consulting Group, Inc.: 4 (https://510kreport.com/company/patterson-consulting-group)
- Radionics, Inc.: 3 (https://510kreport.com/company/radionics)
- Elekta Instruments, Inc.: 3 (https://510kreport.com/company/elekta-instruments)
- I.S.G. Technologies, Inc.: 2 (https://510kreport.com/company/isg-technologies)
- FHC, Inc.: 1 (https://510kreport.com/company/fhc)
- Medtec, Inc.: 1 (https://510kreport.com/company/medtec)
- Nomos Corp.: 1 (https://510kreport.com/company/nomos)
- Rapid Machine & Tool Corp.: 1 (https://510kreport.com/company/rapid-machine-tool)

## Firms that cite its devices most
- Elekta Solutions AB: 4 (https://510kreport.com/company/elekta-solutions)
- Medical Instrumentation & Diagnostics Corp.(Midco): 2 (https://510kreport.com/company/medical-instrumentation-diagnostics-midco)
- Medical Intelligence Medizintechnik GmbH: 2 (https://510kreport.com/company/medical-intelligence-medizintechnik)
- FHC, Inc.: 2 (https://510kreport.com/company/fhc)
- Stabilix, LLC: 2 (https://510kreport.com/company/stabilix)
- 3D Line USA, Inc.: 1 (https://510kreport.com/company/3d-line-usa)
- Oncology Data Systems, Inc.: 1 (https://510kreport.com/company/oncology-data-systems)
- New Business Development, LLC: 1 (https://510kreport.com/company/new-business-development)

## Its most-cited devices
- K960338: Stereotactic Body Frame (1996), cited by 5
- K972324: Leksell Stereotactic System (1998), cited by 3
- K970291: Accessories to the Stereotactic Body Fram (1997), cited by 2
- K080355: Leksell Stereotactic System with Reusable Fixation Screws (2009), cited by 2
- K061941: Leksell Gamma Knife Perfexion, Model 715000 (2006), cited by 2
- K190887: Leksell Vantage Stereotactic System (2019), cited by 2

## Recent decisions
- K190887: Leksell Vantage Stereotactic System (Aug 1, 2019)
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (Mar 30, 2018)
- K173791: Leksell GammaPlan (Feb 9, 2018)
- K171123: Leksell Vantage Stereotactic System (Sep 15, 2017)
- K160440: Leksell Gamma Knife Icon (Apr 20, 2016)
- K152558: Leksell Stereotactic System, Injection/ Aspiration Needle Kit (Mar 2, 2016)
- K151159: Leksell Gamma Knife Perfexion (Oct 29, 2015)
- K151666: Leksell GammaPlan (Sep 3, 2015)

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