# K991578: Smartspot 2000

- Pathway: 510(k) (Special)
- Applicant: Cmt Medical Technologies, Ltd.
- Decided: Jun 3, 1999 after 28 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030544: RFX Fluroscopic Digital Imaging System (2003), 0 descendants of its own

## Indications for use
The SmartSpot 2000 is indicated for the acquisition, storage, processing (enhancement), printing and display of fluoroscopic and digital x-ray spot images.

Source page: https://510kreport.com/device/K991578
Methodology: https://510kreport.com/methodology