# International Remote Imaging Systems

- Location (FDA's records): North Attleboro, MA
- FDA decisions: 3 (1995–2003): 3 510(k) clearances
- Product codes: KQO (2), JJW (1)
- Predicates its devices cite: 5 (1 its own); citations of its devices by later devices: 7 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Boehringer Mannheim Corp.: 2 (https://510kreport.com/company/boehringer-mannheim)

## Firms that cite its devices most
- Arkray, Inc.: 3 (https://510kreport.com/company/arkray)
- Iris International Inc., A Division of Iris Iris I: 1 (https://510kreport.com/company/iris-international-a-division-of-iris-iris-i)
- Iris International, Inc.: 1 (https://510kreport.com/company/iris-international)
- Iris Diagnostics: 1 (https://510kreport.com/company/iris-diagnostics)

## Its most-cited devices
- K013783: Aution Max AX-4280 Urinalysis System (2002), cited by 4
- K030600: Aution Jet AJ-4270 Urine Analyzer (2003), cited by 2
- K945913: Irispec Urine Chemistry Control Part a and B (1995), cited by 1

## Recent decisions
- K030600: Aution Jet AJ-4270 Urine Analyzer (Jul 11, 2003)
- K013783: Aution Max AX-4280 Urinalysis System (Jan 18, 2002)
- K945913: Irispec Urine Chemistry Control Part a and B (Apr 5, 1995)

Source page: https://510kreport.com/company/international-remote-imaging-systems