Intelerad Medical Systems

FDA Regulatory Profile

Intelerad Medical Systems appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2267-2014, Class II) was initiated on July 3, 2014. Its most recent 510(k) clearance was granted on January 24, 2007.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2267-2014Class IIIntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receiveJuly 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K070080INTELEPACSJanuary 24, 2007
K032533INTELEPACSOctober 16, 2003