# K942837: DST-XL

- Pathway: 510(k) (Traditional)
- Applicant: Sopha Medical Systems, Inc.
- Decided: Jan 5, 1995 after 204 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 2 (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
- Mar 10, 2008 · Not classified · Z-2008-2008: GE Healthcare has recently became aware of a cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.
- Sep 27, 2005 · Not classified · Z-0105-06: Cracked welds on the main rotation shaft could potentially lead to the collapse of the gantry yokes that support the detectors if the system is continued to be used after the weld has completely fract

Source page: https://510kreport.com/device/K942837
Methodology: https://510kreport.com/methodology