# Helax AB

- Location (FDA's records): Uppsala, SE
- FDA decisions: 3 (1997–1999): 3 510(k) clearances
- Product codes: MUJ (1), KPQ (1), IYE (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Nomos Corp.: 2 (https://510kreport.com/company/nomos)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)
- Varian Assoc., Inc.: 1 (https://510kreport.com/company/varian-assoc)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Mds Nordion: 1 (https://510kreport.com/company/mds-nordion)
- Nucletron Corp.: 1 (https://510kreport.com/company/nucletron)

## Its most-cited devices
- K993766: Helax-TMS V 5.0 Radiation Therapy Treatment Planning System (1999), cited by 1
- K972617: Helax-Visir (1997), cited by 1

## Recent decisions
- K993766: Helax-TMS V 5.0 Radiation Therapy Treatment Planning System (Dec 8, 1999)
- K982857: Helax-Imcon, Version 1.0 (Nov 4, 1998)
- K972617: Helax-Visir (Oct 1, 1997)

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