Immersivetouch Inc

FDA Regulatory Profile

Immersivetouch Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2041-2020, Class III) was initiated on April 3, 2020. Its most recent 510(k) clearance was granted on October 16, 2023.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2041-2020Class IIIImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative sofApril 3, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K230249IkshanaOctober 16, 2023
K210726ImmersiveTouchSeptember 29, 2021
K181813ImmersiveView Surgical Plan (IVSP®)June 9, 2020
K140860ImmersiveTouch3 and MicrovisTouchDecember 16, 2014