FDA applicant
Intl. Remote Imaging Systems
FDA records 14 decisions for Intl. Remote Imaging Systems (Chatsworth, CA) from 1982 to 2002: 14 510(k) clearances. Most are in product codes KQO (Automated Urinalysis System) and GKL (Counter, Cell, Automated (Particle Counter)). 15 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Intl. Remote Imaging Systems’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Intl. Remote Imaging Systems since 2007.
Recalls per year
2in 2026
Class I Class II/III not classified
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