immersivetouch.comIkshana
Immersivetouch
ImmersiveTouch
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014833795 | 3014833795 | ImmersiveTouch, Inc. | 1 | N | 2026-01-01 | 910 West Van Buren Street Suite #715 Chicago IL US 60607 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B940IMMERSIVEVIEW0 | ImmersiveTouch - The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options. | 7738405227 | sales@immersivetouch.com |
| B940IVZBKIT0 | ImmersiveTouch - ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options. | 7738405227 | sales@immersivetouch.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 221737 | 1061423540 | K230249 | Ikshana | LLZ | 2023-10-16 |
| 221737 | 1496342326 | K210726 | ImmersiveTouch | LLZ | 2021-09-29 |
| 221737 | 1945689488 | K181813 | ImmersiveView Surgical Plan (IVSP®) | DZJ | 2020-06-09 |
| 221737 | 1270662007 | K140860 | ImmersiveTouch3 and MicrovisTouch | LLZ | 2014-12-16 |
Product Codes Associated With Registrations#
PMN#
ImmersiveTouch
ImmersiveTouch, Inc.
ImmersiveView Surgical Plan (IVSP®)
ImmersiveTouch
GUDID#
Ikshana - Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors.Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists.When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.
2024-04-30
ImmersiveTouch - The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
2020-08-07
ImmersiveTouch - ImmersiveTouch is a stand-alone modular software package that allows users to import, visualize, and segment medical images to create accurate 3D representations.
2023-08-28
ImmersiveTouch - ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
2020-08-07