# K982631: Philips Tomoscan CS

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Oct 6, 1998 after 70 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 K944131 (1995). 4 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944326: Philips Tomoscan SR5000, Philips Medical Systems North America, Inc. (1994) Summary page 1.
- K964890: Anatom 2000, Analogic Corp. (1997) Summary page 1.
- K920950: Philips Easyvision, Philips Medical Systems, Inc. (1992) Summary page 1.

## Most influential descendants
- K991278: Philips Tomoscan AV-NT (1999), 17 descendants of its own
- K014240: Pronto (2002), 16 descendants of its own
- K040902: Hitachi Presto (2004), 15 descendants of its own
- K071806: Eclos Computed Tomography X-Ray System (2007), 12 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own

## Indications for use
The TOMOSCAN CS is a whole body Computed Tomography (CT) system which is a diagnostic X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. It includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. It is used for the display, storage and analysis of digital diagnostic CT images. The TOMOSCAN CS is intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.

Source page: https://510kreport.com/device/K982631
Methodology: https://510kreport.com/methodology