# K964747: Somatom Plus 4 CT Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 10, 1997 after 76 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: 1 generation back to K940606 (1994). 2 ancestors in all.
265 later devices descend from it; 1 cites it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941546: Somatom Project 059, Siemens Corp. (1994) Summary page 2.
- K940606: Hispeed Advantage II, GE Medical Systems (1994) Summary page 2.

## Most influential descendants
- K982060: Volumax CT Imaging System (1998), 264 descendants of its own
- K012009: MX8000 Idt CT System (2001), 263 descendants of its own
- K033326: Philips Plus Computed Tomography System (2003), 214 descendants of its own
- K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner (2004), 147 descendants of its own
- K130159: Qlab Quantification Software Heart Model (2013), 92 descendants of its own

## Indications for use
The SOMATOM Plus 4 CT Scanner is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

Source page: https://510kreport.com/device/K964747
Methodology: https://510kreport.com/methodology