Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list ImmersiveTouch with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Oct 16, 2023: Ikshana.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 16, 2023 | IkshanaK230249 · LLZ | 510(k) clearances |
| Sep 29, 2021 | ImmersiveTouchK210726 · LLZ | 510(k) clearances |
| Jun 9, 2020 | ImmersiveView Surgical Plan (IVSP®)K181813 · DZJ | 510(k) clearances |
| Apr 3, 2020 | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgClass III · Observed an internal repetitive software glitch in ImmersiveView. | Device recalls |
| Dec 16, 2014 | ImmersiveTouch3 and MicrovisTouchK140860 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
