# K080890: Smartspot Primax

- Pathway: 510(k) (Special)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Apr 29, 2008 after 29 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911454 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961307: Smart Spot, Cmt Medical Technologies, Ltd. (1996) Summary page 1.

## Indications for use
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1 024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies

Source page: https://510kreport.com/device/K080890
Methodology: https://510kreport.com/methodology