# K112276: Vizion

- Pathway: 510(k) (Traditional)
- Applicant: Trek Diagnostic Systems
- Decided: Nov 16, 2011 after 99 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sensititre® Vizion® is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Hczemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp. NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references. This 510(k) is for the addition of: “Vizion® for reading Sensititre YeastOne Plates” The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. The “Vizion” can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.

Source page: https://510kreport.com/device/K112276
Methodology: https://510kreport.com/methodology