# Elekta Instruments, Inc.

- Location (FDA's records): Atlanta, GA
- FDA decisions: 8 (1992–1999): 8 510(k) clearances
- Product codes: HCH (1), JAI (1), IWB (1), HWE (1), HRS (1), GXD (1), HAW (1), GEY (1)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 16 (0 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aesculap, Inc.: 2 (https://510kreport.com/company/aesculap)
- Codman & Shurtleff, Inc.: 2 (https://510kreport.com/company/codman-shurtleff)
- Aesculap Instruments Corp.: 1 (https://510kreport.com/company/aesculap-instruments)
- Downs Surgical, Ltd.: 1 (https://510kreport.com/company/downs-surgical)

## Firms that cite its devices most
- Medartis AG: 4 (https://510kreport.com/company/medartis)
- Elekta Instrument AB: 3 (https://510kreport.com/company/elekta-instrument)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- Mizuho America, Inc.: 1 (https://510kreport.com/company/mizuho-america)
- Nmt Medical, Inc.: 1 (https://510kreport.com/company/nmt-medical)
- Mds Nordion: 1 (https://510kreport.com/company/mds-nordion)
- Aktina Medical Physics Corp.: 1 (https://510kreport.com/company/aktina-medical-physics)
- Gistlstrasse: 1 (https://510kreport.com/company/gistlstrasse)

## Its most-cited devices
- K955064: Spetzler TI 100 Aneurysm Clip (1996), cited by 6
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System (1995), cited by 4
- K983678: Elekta Oncology Systems Precise Treatment Table (1999), cited by 2
- K914808: Leksell Gammaplan (LGP) (1992), cited by 2
- K943468: Leksell Surgiplan (1995), cited by 2

## Recent decisions
- K983678: Elekta Oncology Systems Precise Treatment Table (Jan 15, 1999)
- K955064: Spetzler TI 100 Aneurysm Clip (Oct 17, 1996)
- K941823: Leksell Neuro Generator and Accessories (Mar 22, 1996)
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System (May 23, 1995)
- K943468: Leksell Surgiplan (Jan 20, 1995)
- K932261: ES-100 Accessories (Jan 7, 1994)
- K925360: ES-100 Power System, ES-100 Series (Sep 7, 1993)
- K914808: Leksell Gammaplan (LGP) (Jan 23, 1992)

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