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INTELERAD MEDICAL SYSTEMS INCORPORATED

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0723-2026Class IIIntelePACS - InteleConnect / TechPortalOctober 17, 2025
Z-1208-2025Class IIIntelePACS (Image Fusion Module) - InteleViewerFebruary 5, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K192176IntelePACSApril 2, 2020
K150707IntelePACSMay 27, 2015
K083520INTELEPACS, MODEL VERSION 3.X.XJune 23, 2009