Innovative Magnetic Resonance Imaging Systems Inc.

FDA Regulatory Profile

Innovative Magnetic Resonance Imaging Systems Inc. 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-0428-2013, Class II) was initiated on October 19, 2012. Its most recent 510(k) clearance was granted on February 15, 2005.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0428-2013Class IIIMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both thOctober 19, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K050132NEURO II-SFebruary 15, 2005
K002964NEURO IIDecember 19, 2000