Chest X-Ray Computer-Aided Detection
Marks possible findings on a plain chest X-ray.
The chest X-ray is the most ordered imaging test in the world, so software that reads one has an enormous potential reach.
This particular device type has only a handful of clearances, and that gap between how often the test is done and how little is cleared under this code is worth noticing. Much of the recent chest AI work has gone through the triage and prioritization device types instead, where the permitted claim is narrower.
When a vendor pitches chest X-ray AI, the first question is which code it cleared under, because that decides what the product is allowed to tell your team.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- OMJ
- FDA name for it
- Chest X-Ray Computer Aided Detection
- Rule number
- 21 CFR 892.2050
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask which findings it is cleared to mark. Chest AI marketing often lists far more findings than the clearance covers.
- Ask how it behaves on portable films taken at the bedside, which look nothing like the clean images in a validation set.
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| IQQA-CHEST SOFTWARE PACKAGE | Edda Technology, Inc. | October 8, 2004 | K042408 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.