CT Colonography Computer-Aided Detection
Flags possible polyps on a CT scan of the colon, as a second read.
A small and specific group: software that marks possible polyps on a CT colonography study.
CT colonography is a demanding read. The reader works through a long dataset looking for small bumps, and attention drifts. Software that marks candidates for a second look targets exactly that drift.
It is worth knowing this list is short and has not grown much, which itself says something about where the field put its effort.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- NWE
- FDA name for it
- Colon Computed Tomography System, Computer Aided Detection
- Rule number
- 21 CFR 892.2050
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask about performance by polyp size. The small ones are the ones that get missed and the ones models struggle with.
- Ask how much extra reading time the marks add in practice.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Siemens Medical Solutions USA, Inc. | 1 |
| Medicsight Plc | 1 |
| Medicsight | 1 |
| Siemens AG Medical Solutions | 1 |
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 |
|---|---|---|---|
| SYNGO.CT COLONOGRAPHY | Siemens Medical Solutions USA, Inc. | December 3, 2014 | K140920 |
| COLONCAD API 3.1 | Medicsight Plc | May 17, 2011 | K083423 |
| COLON CAR 1.2 | Medicsight | October 19, 2004 | K042674 |
| COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | October 8, 2004 | K042605 |
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.