# K983140: CT Biopsyview

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Nov 4, 1998 after 57 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 K965004 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965004: C.a.R.E. Vision for the Somatom Plus 4 CT Scanner, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.

## Cited in the summary but kept off the family tree
- K950572: Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The CT BiopsyView option is intended to be used for instant display of CT images during interventional procedures. The instant display of images allows the operating physician to watch the ptacement of an interventional instrument in real-time. CT BiopsyView is an option to the TOMOSCAN family of CT systems. TOMOSCAN systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems 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. They 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. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment. The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include its use by a physician in the interventional phases of patient conditions and treatment.

Source page: https://510kreport.com/device/K983140
Methodology: https://510kreport.com/methodology