Device product
PhenoMATRIX
Z-1812-2025
Product summary
- Firm
- Copan WASP
- Event
- Event 96765
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-1812-2025
Official wording
Reason: 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.
Code information: All software versions
Distribution pattern: US: Nationwide distribution in the states of UT, AR, CA, PA, MD, NC, IL, MA, NJ, KS, TX, NY, NV.
Derived failure modes
-
Unknown
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.