# K081520: Sensititre Vizion

- Pathway: 510(k) (Special)
- Applicant: Trek Diagnostic Systems, Inc.
- Decided: Oct 24, 2008 after 147 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. The FDA summary names no predicate by number.

## Indications for use
The Sensititre® Vizion® is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® Vizion® is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of 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 Haemophilus influenzae, Streptococcus pneumoniae and Streptococci other than S. pneumoniae. NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert for additional instructions, limitations, and references.

Source page: https://510kreport.com/device/K081520
Methodology: https://510kreport.com/methodology