# K961871: Flourospot T.O.P.

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 31, 1996 after 77 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: 1 generation back to K914525 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914525: Flurospot H Version 2, Siemens Medical Solutions USA, Inc. (1991) Summary page 3.
- K933664: Polytron T.O.P. (Time, Operation, Performance), Siemens Gammasonics, Inc. (1993) Summary page 3.
- K933299: QL Multipulse 2048, Infimed, Inc. (1993) Summary page 3.

## Most influential descendants
- K982028: Fluorospot Compact (1998), 0 descendants of its own

## Indications for use
The Fluorospot T.O.P. is intended for use with radiographic/fluoroscopic and universal interventional angiography x-ray systems to digitally acquire, record and display radiographic images. The Fluorospot T.O.P. enables the trained healthcare professional to consistently acquire high quality images for fluoroscopic examinations with contrast medium, digital tomographical exposures. urological examinations, vascular and non-vascular procedures as well as general angiography, interventional angiography, peripheral angiography and DSA (Digital Subtraction Angiography).

Source page: https://510kreport.com/device/K961871
Methodology: https://510kreport.com/methodology