# K933664: Polytron T.O.P. (Time, Operation, Performance)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Gammasonics, Inc.
- Decided: Dec 15, 1993 after 140 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961871: Flourospot T.O.P. (1996), 1 descendant of its own
- K991922: Digital Imaging System (BSR) (1999), 0 descendants of its own
- K982028: Fluorospot Compact (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K933664
Methodology: https://510kreport.com/methodology