IMPRIS Imaging Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0164-2026Class IIMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, VidaSeptember 30, 2025
Z-0163-2026Class IIMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDASeptember 30, 2025
Z-0162-2026Class IIMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, SkyraSeptember 30, 2025
Z-0161-2026Class IIMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI MagnetSeptember 30, 2025