Alltech Medical Systems America Inc

FDA Regulatory Profile

Alltech Medical Systems America Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1061-2015, Class I) was initiated on January 9, 2015. Its most recent 510(k) clearance was granted on April 10, 2017.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1061-2015Class IEchostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.January 9, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K163192Comfort EC710April 10, 2017
K141945ECHOSTAR COMFORT 1.5T MRIFebruary 3, 2015
K113511ECHOSTAR SPICA 1.5T MR SYSTEMMay 2, 2012
K082100ALLTECH ECHOSTAR 1.5 T MR SYSTEMAugust 6, 2008