# K101861: Truevision 3D Visualization and Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Truevision Systems, Incorporated
- Decided: Dec 22, 2010 after 173 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896095 (1990). 15 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963333: Optronics Epic Color Television Camera System (S97340), Karl Storz Imaging, Inc. (1996) Summary page 2.
- K980295: Ophthavision Imaging System, Mrp Group, Inc. (1998) Summary page 2.
- K082364: Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or Digital Imaging Software for, Topcon Corp. (2008) Summary page 2.
- (no number) TrueVision®- Visualization System for Microsurgery, Class 1 Device: named in the summary without a submission number

## Most influential descendants
- K141068: Zeiss Cataract Suite Markerless (2014), 8 descendants of its own
- K123464: Callisto Eye (2013), 6 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own
- K143275: IOLMaster700 (2015), 4 descendants of its own
- K170171: IOLMaster 700 (2017), 3 descendants of its own

## Indications for use
The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates.

Source page: https://510kreport.com/device/K101861
Methodology: https://510kreport.com/methodology