# Direx Systems Corp.

- Location (FDA's records): Canton, MA
- FDA decisions: 22 (2003–2012): 22 510(k) clearances
- Product codes: IYE (9), LNS (7), MUJ (3), OXO (2), IXI (1)
- Predicates its devices cite: 50 (23 its own); citations of its devices by later devices: 25 (23 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
- Medirex, Inc.: 4 (https://510kreport.com/company/medirex)
- Brainlab AG: 3 (https://510kreport.com/company/brainlab)
- Permedics, Inc.: 2 (https://510kreport.com/company/permedics)
- KARL STORZ Endoscopy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Karl Storz Lithotripsy-America, Inc.: 2 (https://510kreport.com/company/karl-storz-lithotripsy-america)
- Dornier Medtech America, Inc.: 2 (https://510kreport.com/company/dornier-medtech-america)
- Brainlab Med. Computersysteme GmbH: 2 (https://510kreport.com/company/brainlab-med-computersysteme)
- 3D Line USA, Inc.: 1 (https://510kreport.com/company/3d-line-usa)

## Firms that cite its devices most
- United Medical Systems, Inc.: 2 (https://510kreport.com/company/united-medical-systems)

## Its most-cited devices
- K053640: Integra (2006), cited by 4
- K041582: Modification to Tripter X-1 Compact Duet (2004), cited by 4
- K023535: Tripter X-1 Compact Duet (2003), cited by 4
- K040553: Modification to Acculeaf (2004), cited by 3
- K041213: 3DSCOPE (2004), cited by 2
- K062147: Integra SL (2006), cited by 1

## Recent decisions
- K111947: Duet Magna (Mar 1, 2012)
- K102765: Pronex (Dec 7, 2010)
- K072529: Trackport (Oct 26, 2007)
- K071701: Trackleaf-10 (Jul 23, 2007)
- K063482: Crossplan / Accusoft-XL V.4.04 (Dec 14, 2006)
- K062147: Integra SL (Oct 20, 2006)
- K062032: Accusoft, Accusoft XL (Oct 5, 2006)
- K061873: VERT-X (Aug 18, 2006)

Source page: https://510kreport.com/company/direx-systems