IMRIS Imaging Inc
FDA Regulatory Profile
IMRIS Imaging Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1034-2026, Class II) was initiated on December 8, 2025. Its most recent 510(k) clearance was granted on August 6, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1034-2026 | Class II | Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119 | December 8, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252239 | InVision 3T Recharge Operating Suite | August 6, 2025 |