# K921192: CT Sytec 6000 Computed Tomography System

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Oct 20, 1992 after 222 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 1, 2008 · Not classified · Z-2225-2009: During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requiremen

Source page: https://510kreport.com/device/K921192
Methodology: https://510kreport.com/methodology