IMRIS Imaging Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1034-2026Class IIBrand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119December 8, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K252239InVision™ 3T Recharge Operating SuiteAugust 6, 2025