ImmersiveTouch, Inc.
Chicago, IL, US
ImmersiveTouch, Inc. appears in FDA device records in Chicago, IL. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for ImmersiveTouch, Inc. between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230249 | Ikshana | LLZ | Substantially Equivalent | |
| K210726 | ImmersiveTouch | LLZ | Substantially Equivalent | |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | DZJ | Substantially Equivalent | |
| K140860 | ImmersiveTouch3 and MicrovisTouch | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014833795 | 3014833795 | ImmersiveTouch, Inc. | 910 West Van Buren Street, Chicago, IL 60607 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2041-2020 | ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options | Observed an internal repetitive software glitch in ImmersiveView. | Class III | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain