# K931193: Sim-400 System

- Pathway: 510(k) (Traditional)
- Applicant: Scinticor, Inc.
- Decided: Jun 21, 1993 after 104 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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; 1 cites 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
- K023373: Onepass Nuclear Imaging System, Model 70-500101 (2003), 2 descendants of its own
- K072191: Clearvision Nuclear Medicine Imaging System (2007), 0 descendants of its own
- K051402: Onepass Nuclear Medicine Imaging System (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K931193
Methodology: https://510kreport.com/methodology