# K182147: CTXX85

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corporation
- Decided: Sep 7, 2018 after 30 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
Longest line of descent: 6 generations back to K982349 (1998). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172058: CT6485, CT12885, Analogic Corporation (2018) Summary page 4.

## Most influential descendants
- K201231: CTxx85 CT Scanner (2021), 0 descendants of its own

## Indications for use
The Analogic CTXX85 CT Scanner systems are intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The CTXX85 CT Scanner systems are indicated for pediatric and adult patients.

Source page: https://510kreport.com/device/K182147
Methodology: https://510kreport.com/methodology