# K974344: CT Scope

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jun 3, 1998 after 196 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 K930090 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K930090: Helicat, Elscint, Inc. (1993) Summary page 1.
- K950972: Real-Time Reconstruction System Model TSXF-001A, Toshiba America Medical Systems, In.C (1996) Summary page 1.
- K970606: Computed Tomography X-Ray System, GE Medical Systems (1997). Our OCR of the scanned summary read K970600, FDA’s number for Dermamend Foam Island Dressing (Dermarx Corp.). Corrected to the number one digit away that FDA lists under the company the summary names beside it.

## Indications for use
Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

Source page: https://510kreport.com/device/K974344
Methodology: https://510kreport.com/methodology