# Arkray, Inc.

- Location (FDA's records): Cortlandt Manor, NY
- FDA decisions: 18 (2002–2024): 18 510(k) clearances
- Product codes: JIL (3), KQO (2), CIC (2), PZI (1), LCP (1), LKM (1), CGX (1), CGS (1), JJF (1), CIG (1), QRL (1), CHH (1)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- International Remote Imaging Systems: 3 (https://510kreport.com/company/international-remote-imaging-systems)
- Sysmex America, Inc.: 2 (https://510kreport.com/company/sysmex-america)
- Nova Biomedical Corp.: 1 (https://510kreport.com/company/nova-biomedical)
- Roche Diagnostic Systems, Inc.: 1 (https://510kreport.com/company/roche-diagnostic-systems)
- Iris International, Inc.: 1 (https://510kreport.com/company/iris-international)
- Bayer Corp.: 1 (https://510kreport.com/company/bayer)
- Roche Diabetes Care, Inc.: 1 (https://510kreport.com/company/roche-diabetes-care)

## Firms that cite its devices most
- Urit Medical Electronic Co., Ltd.: 1 (https://510kreport.com/company/urit-medical-electronic)
- Taidoc Technology Corporation: 1 (https://510kreport.com/company/taidoc-technology)

## Its most-cited devices
- K093098: Aution Max Model AX-4030 Urinalysis System (2009), cited by 4
- K200788: Assure Titanium Blood Glucose Monitoring System (2022), cited by 1

## Recent decisions
- K232416: AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
- K193514: AUTION MAX AX-4060 Urinalysis System (Apr 13, 2023)
- K221175: Multi-Lancet Device 2, ReliOn Premier Lancing Device (Oct 17, 2022)
- K200788: Assure Titanium Blood Glucose Monitoring System (May 23, 2022)
- K160062: AUTION ELEVEN Semi-Automated Urinalysis System (Oct 7, 2016)
- K121456: Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips; Aution Control (Feb 1, 2013)
- K093098: Aution Max Model AX-4030 Urinalysis System (Dec 23, 2009)
- K053401: Spotchem II Chemistry Basic 1 and Chemistry Basic 2 Tests (Mar 24, 2006)

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