# Anzai Medical Co., Ltd.

- Location (FDA's records): Brookeville, MD
- FDA decisions: 4 (2002–2017): 4 510(k) clearances
- Product codes: LHN (3), IYX (1)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 6 (2 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
- Health Policy Resorters Group, LLC: 1 (https://510kreport.com/company/health-policy-resorters-group)
- Varian Medical Systems, Inc.: 1 (https://510kreport.com/company/varian-medical-systems)

## Firms that cite its devices most
- General Equipment For Medical Imaging, S.A.: 1 (https://510kreport.com/company/general-equipment-for-medical-imaging)
- Aktina Medical Corporation: 1 (https://510kreport.com/company/aktina-medical)
- Hybridyne Imaging Technologies, Inc.: 1 (https://510kreport.com/company/hybridyne-imaging-technologies)
- Empnia, Inc.: 1 (https://510kreport.com/company/empnia)

## Its most-cited devices
- K022342: EZ-Scope an, EZ-Scope Light (2002), cited by 2
- K031385: Anzai AZ-733 Respiratory Gating System (2003), cited by 2
- K160432: Anzai Respiratory Gating System (2016), cited by 1
- K170719: Anzai Respiratory Gating System (2017), cited by 1

## Recent decisions
- K170719: Anzai Respiratory Gating System (Apr 5, 2017)
- K160432: Anzai Respiratory Gating System (Apr 22, 2016)
- K031385: Anzai AZ-733 Respiratory Gating System (Nov 10, 2003)
- K022342: EZ-Scope an, EZ-Scope Light (Oct 9, 2002)

Source page: https://510kreport.com/company/anzai-medical