Data / Medical devices / United States / ImmersiveTouch, Inc.

ImmersiveTouch, Inc.: FDA-registered device maker in Chicago, IL, United States, 4 510(k) clearances

Name: ImmersiveTouch, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

ImmersiveTouch, Inc. is registered with the FDA (registration 3014833795) in Chicago, IL, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 16, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014833795
Address: 910 West Van Buren Street Suite #715, Chicago, IL, United States, 60607
Owner or operator: ImmersiveTouch (10058372)
Roles: Manufacturer
First device listed: September 5, 2018
Registered through: 2026
Brand names listed: Ikshana, ImmersiveTouch, ImmersiveTouch3, ImmersiveView Surgical Plan, MicrovisTouch

Devices it lists

Device	Product code	Class	Role	Source
Driver, Wire, And Bone Drill, Manual	DZJ	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 16, 2023	K230249	Ikshana	LLZ	Substantially Equivalent	Immersivetouch	accessdata.fda.gov
September 29, 2021	K210726	ImmersiveTouch	LLZ	Substantially Equivalent	Immersivetouch, Inc.	accessdata.fda.gov
June 9, 2020	K181813	ImmersiveView Surgical Plan (IVSP®)	DZJ	Substantially Equivalent	Immersivetouch	accessdata.fda.gov
December 16, 2014	K140860	ImmersiveTouch3 and MicrovisTouch	LLZ	Substantially Equivalent	Immersivetouch	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 3, 2020	85475	Class III	Ongoing	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.	accessdata.fda.gov

Compare with other makers

Updated October 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.