# K190074: Presero 3D Scanning System

- Pathway: 510(k) (Traditional)
- Applicant: Certis Health
- Decided: Feb 14, 2019 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K924630 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142107: Echo True 3D Viewer, Echopixel, Inc. (2015) Summary page 4.
- K131596: Wound Measuring & Monitoring Device, Woundvision, LLC (2013) Summary page 6.

## Indications for use
The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K190074
Methodology: https://510kreport.com/methodology