INTELERAD MEDICAL SYSTEMS INCORPORATED

FDA Regulatory Profile

INTELERAD MEDICAL SYSTEMS INCORPORATED appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0723-2026, Class II) was initiated on October 17, 2025. Its most recent 510(k) clearance was granted on April 2, 2020.

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