# K870513: CSI/3D

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Scientific, Inc.
- Decided: May 8, 1987 after 92 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K131528: Non-Pyrogenic Ultrasound Transducer Cover (2013), 1 descendant of its own
- K222460: Intraoperative Ultrasound Probe Cover (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K870513
Methodology: https://510kreport.com/methodology