# K172058: CT6485, CT12885

- Pathway: 510(k) (Traditional)
- Applicant: Analogic Corporation
- Decided: Feb 13, 2018 after 222 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: 5 generations back to K982349 (1998). 7 ancestors in all.
2 later devices descend 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)
- K103127: Somatom Definition as, Siemens Medical Solutions USA, Inc. (2011) Summary page 4.
- K120579: Somatom Definition Edge, Siemens Medical Systems, Inc. (2012) Summary page 4.

## Most influential descendants
- K182147: CTXX85 (2018), 1 descendant of its own
- K201231: CTxx85 CT Scanner (2021), 0 descendants of its own

## Indications for use
The Analogic CTXX85 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 systems are indicated for pediatric and adult patients.

Source page: https://510kreport.com/device/K172058
Methodology: https://510kreport.com/methodology