Ask for the K-number before you watch the demo.

Somewhere on your calendar this quarter there's a vendor demo, and somewhere in that deck is the phrase "FDA-cleared AI." I pulled the agency's own 510(k) database this morning to see what's actually behind that phrase — and the list is longer than any rep will tell you: 45 radiology-panel clearances since June 1. Koios DS 3.8. MammoScreen 5. RadOncAI. MediAI-OA. A new Siemens coronary cockpit. Six weeks of product.

And here's what surprised me: this isn't a flood year. It's the steady state. FDA cleared 451 radiology-panel devices in 2023, 415 in 2024, 480 in 2025 — and 2026 is running right on that pace, 247 through mid-July. Call it eight or nine a week, every week. The rep in your lobby picked one of the nine. The question is what the clearance behind it actually says.

The flood isn't new. The drumbeat is the point — and the database is more honest than the deck.

Read that twice, because it's the whole game: equivalent, not superior. A 510(k) clearance says the device is as safe and effective as something already on the market — the "predicate." It is a real bar, and it is not the bar the sales deck implies. My position: the clearance is where your due diligence starts, not where it ends — and every piece of it is public.

Fair is fair: clearance is a floor, not nothing — and it isn't an endorsement either. The higher bar (PMA, with clinical trials) applies to a different class of device entirely. Counts above are radiology-panel (advisory committee "RA") totals computed from FDA's openFDA database this morning; the database updates continuously.

Sources (primary, verified today): FDA openFDA 510(k) database — all counts (45 since June 1; 247 in 2026; 451/415/480 for 2023–2025) computed directly from the agency's API this morning · FDA, "Premarket Notification 510(k)" — definition quoted verbatim · device names from the individual clearance records. Caveat: panel code "RA" is FDA's radiology advisory committee — a handful of listed devices (ultrasound gel, generic DR panels) are radiology-adjacent hardware, not AI.

There's a vendor demo on your calendar this quarter, and somewhere in that deck it says "FDA-cleared AI."

I pulled FDA's own 510(k) database this morning. 45 radiology-panel clearances since June 1 — MammoScreen 5, Koios DS 3.8, RadOncAI, MediAI-OA, and forty more. And that's not a flood year: 451 in 2023, 415 in 2024, 480 in 2025, and 2026 running right on pace. Eight or nine new radiology devices clear every single week. Your rep picked one of the nine.

Here's what "cleared" means, verbatim from FDA: "as safe and effective, that is, substantially equivalent, to a legally marketed device."

Equivalent. Not superior. A 510(k) says the product matches something already on the market — the predicate. Real bar. Not the bar the deck implies.

So three questions before any demo:
1. What's the K-number? Look it up at accessdata.fda.gov and read the testing section of the 510(k) summary. It's public and it's two pages.
2. What's the predicate? Knowing whose shoulders a product stands on changes the conversation.
3. If the pitch says AI — is it on FDA's AI-enabled device list? Checking takes a minute. Reps don't expect you to.

The database is more honest than the deck. Start there.

FIRST SOURCE · one verified original-source finding, composed for one reader · this edition: independent imaging and radiology practices