# K982028: Fluorospot Compact

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 14, 1998 after 35 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K914525 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961871: Flourospot T.O.P., Siemens Medical Solutions USA, Inc. (1996) Summary page 1.
- K914525: Flurospot H Version 2, Siemens Medical Solutions USA, Inc. (1991) Summary page 1.
- K911082: Real Time X-Ray Imaging System, Siemens Medical Solutions USA, Inc. (1991) Summary page 1.

## Indications for use
The Fluorospot Compact digital imaging system, is an optional integral component of a radiographic/fluoroscopic x-ray system, as such it is not considered a stand alone device. The Fluorospot Compact is intended for use with x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot Compact enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, urological examinations as well as vascular and non-vascular procedures.

Source page: https://510kreport.com/device/K982028
Methodology: https://510kreport.com/methodology