FDA.reportPublic FDA data

ImmersiveTouch

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30148337953014833795ImmersiveTouch, Inc.1N2026-01-01910 West Van Buren Street Suite #715 Chicago IL US 60607

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B940IMMERSIVEVIEW0ImmersiveTouch - The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.7738405227sales@immersivetouch.com
B940IVZBKIT0ImmersiveTouch - 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.7738405227sales@immersivetouch.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2217371061423540K230249IkshanaLLZ2023-10-16
2217371496342326K210726ImmersiveTouchLLZ2021-09-29
2217371945689488K181813ImmersiveView Surgical Plan (IVSP®)DZJ2020-06-09
2217371270662007K140860ImmersiveTouch3 and MicrovisTouchLLZ2014-12-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ32023-10-16
DZJ12020-06-09

PMN#

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.

IMMERSIVETOUCH, INC.

2024-04-30