Ask a health system how many AI agents it has deployed and you’ll hear 50. Run the audit and it’s 76. Here is the entire universe of clinical AI that the federal government actually counts — 125 clearances, eleven years — so you can see how small the counted part is.
Sarah Richardson’s line on this week’s Newsday: ask a health system how many agents it’s running, then run the audit and add fifty percent. Fifty on the slide, seventy-six in the building. Bill Russell’s sharper follow-on from the same segment — most of that AI arrived through Workday, ServiceNow and the EHR, not through anything resembling procurement.
So it’s worth knowing what the counted universe looks like, because there is one. FDA runs a product-code taxonomy, and a handful of those codes explicitly name computer-aided detection, machine learning, or artificial intelligence. Every 510(k) cleared under one of them is a clinical AI product that a federal agency has a file on.
Each circle is one clearance. Vertical position is the FDA product code it was cleared under; horizontal position is the decision date. Hover any dot for the device, the firm, and the K number.
It isn’t 125 products. Flip the counter to distinct product families — the same firm re-clearing the same trade name is one product with a version history, not a new capability. Aidoc alone accounts for 17 of the 125 clearances, nearly all of them BriefCase. The headline number is a filing count wearing an innovation costume.
It isn’t medicine. Push the floor past a handful and everything outside two specialties disappears. Pathology has one clearance in eleven years. Neurology has one, and it is a hair-transplant robot. If your slide says clinical AI is diffusing across the house of medicine, the federal record says it is diffusing across radiology and a corner of cardiology.
The counted universe and the deployed universe barely overlap. A scribe, a prior-auth agent, a ServiceNow ticket triager, a scheduling bot, an ambient CDS assistant — none of them are 510(k) devices, so none of them are in this chart, and the chart is still the only inventory anybody has. Your agent inventory has to be built by you, because nobody else is building it. Name, owner, model, data touched, how to switch it off.
The chart above spans eleven and a half years, the entire country, and every firm that has ever cleared an AI-coded device. Below, the same 125 against what one health system found in one afternoon.
Your tool gets counted whether or not anyone tells you. Ship the inventory line before the audit asks for it.