# K140860: ImmersiveTouch3 and MicrovisTouch

- Pathway: 510(k) (Traditional)
- Applicant: Immersivetouch
- Decided: Dec 16, 2014 after 257 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924630 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123023: Surgery Rehearsal Platform, Surgical Theater, LLC (2013) Summary page 4.
- K112387: Procedure Rehearsal Studio (TM), Simbionix, Ltd. (2011) Summary page 4.

## Recalls of this device
- Apr 3, 2020 · Class III · Z-2041-2020: Observed an internal repetitive software glitch in ImmersiveView.

## Indications for use
The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.

Source page: https://510kreport.com/device/K140860
Methodology: https://510kreport.com/methodology