# K982060: Volumax CT Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Sep 2, 1998 after 83 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: 2 generations back to K930090 (1993). 6 ancestors in all.
264 later devices descend from it; 1 cites it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945512: HRSW Option for CT Twin Flash, Elscint, Inc. (1995) Summary page 1.
- K961464: Select/SP, Elscint, Inc. (1996) Summary page 1.
- K941546: Somatom Project 059, Siemens Corp. (1994) Summary page 1.
- K964747: Somatom Plus 4 CT Scanner, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K132165: Qlab Quantification Software (2013), 91 descendants of its own

## Indications for use
Whole body computerized tomography.

Source page: https://510kreport.com/device/K982060
Methodology: https://510kreport.com/methodology