PhenoMATRIX
AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.
US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2025