Total clearances
3
2020-06-09 → 2023-10-16
Name variants in FDA filings: Immersivetouch, Inc. / Immersivetouch
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
2 |
2023-10-16 |
| DZJ |
Driver, Wire, And Bone Drill, Manual |
Class II |
Dental |
1 |
2020-06-09 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2020-04-03 |
Class III
|
Ongoing |
Z-2041-2020 |
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating… |
— |
Observed an internal repetitive software glitch in ImmersiveView. |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-10-16 |
K230249 |
Ikshana |
LLZ |
Class II |
Radiology |
| 2021-09-29 |
K210726 |
ImmersiveTouch |
LLZ |
Class II |
Radiology |
| 2020-06-09 |
K181813 |
ImmersiveView Surgical Plan (IVSP®) |
DZJ |
Class II |
Dental |