510(k) Report

FDA applicant

International Remote Imaging Systems

North Attleboro, MA3 decisions1995–20032 recalls

FDA records 3 decisions for International Remote Imaging Systems (North Attleboro, MA) from 1995 to 2003: 3 510(k) clearances. Most are in product codes KQO (Automated Urinalysis System) and JJW (Urinalysis Controls (Assayed And Unassayed)). Its devices cite 5 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided International Remote Imaging Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for International Remote Imaging Systems since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — International Remote Imaging Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KQOAutomated Urinalysis System2decisions
  • JJWUrinalysis Controls (Assayed And Unassayed)1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 20024cite it
  • K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 20032cite it
  • K945913Irispec Urine Chemistry Control Part a and BInternational Remote Imaging Systems · 19951cites it

What has FDA decided for it lately?

  • K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
  • K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
  • K945913Irispec Urine Chemistry Control Part a and BInternational Remote Imaging Systems · 19952 recalls

All 3 as International Remote Imaging Systems →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K945913IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number…Jul 9, 2012Class III
  • K945913IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.Apr 29, 2005