Yesterday npj Digital Medicine published the number almost nobody publishes: what 13 physicians could do without the AI. The tool in that study — Sonio Suspect — was FDA-cleared 522 days earlier. Here is every imaging-AI clearance since 2016, one dot each, and the column that would tell you which ones ever ran that arm.
Each dot is one 510(k) clearance in an imaging-AI product code: the date FDA decided, against how many days the review took. Color is what the device is allowed to claim — detection/diagnosis (it calls a finding), triage/notification (it flags a case), quantification/processing (it measures or segments). The ringed dot is Sonio Suspect.
There is no column for the baseline. A 510(k) record tells you the device, the predicate, the panel and the calendar. It does not tell you whether a human ever read the same cases without the tool. Sonio Suspect cleared on 2025‑02‑21 in 91 days; the multireader study reporting 54.2% unassisted sensitivity landed 522 days later, on 2026‑07‑28. For the other 368 dots you cannot tell from this ledger whether that arm exists, because the ledger was never designed to ask.
Four in five of these devices never had to face the question. Only 74 clearances sit in a detection/diagnosis code. 194 — more than half — are QIH, "automated radiological image processing": segment it, measure it, hand it back. The reader-study design that produces an unassisted arm is the natural fit for the 20% lane, and the boom you keep reading about is mostly the other 80%.
The market is 65 companies deep, not 184. 250 of 369 clearances (68%) come from firms with more than one. Aidoc alone has 27 — 7% of the entire landscape, at a median 81-day review against 180 days for the one-and-done filers. If you are a first-time filer budgeting off the headline median, you are budgeting off somebody else's tenth submission.
Clearances per year in this same set. The 2026 bar is hollow because the data stops mid-July; the dashed cap is the straight-line annualization. Tick the box and watch the "decline" become a record year.