# K961307: Smart Spot

- Pathway: 510(k) (Traditional)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Jul 1, 1996 after 88 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911454 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911454: FC2000, S & S Inficon, Inc. (1991) Summary page 1.

## Most influential descendants
- K080890: Smartspot Primax (2008), 0 descendants of its own

## Recalls of this device
- Feb 23, 2006 · Not classified · Z-0533-06: When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images.

## Indications for use
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques. 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/K961307
Methodology: https://510kreport.com/methodology