We have two versions of our device - one that's fully automated (the one requiring a 510k), and another where results are manually confirmed post computer visio

We have two versions of our device - one that's fully automated (the one requiring a 510k), and another where results are manually confirmed post computer vision in-house before being tabulated (this is classified as a "manual count" or hemacytometer). To start off distributing, we're shipping with the Class 1 version to beta users and early locations. Once the FDA clears our algorithms to be fully automated (under class 2), that won't be needed anymore. Let me know if that makes sense