# K993791: CT Perfusion Option

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, Inc.
- Decided: Nov 24, 1999 after 15 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 K913475 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K830739: Pro-Guard, Surgicot, Inc. (1983). Our OCR of the scanned summary read K830739, FDA’s number for Pro-Guard (Surgicot, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GEMS CT 9800 Regional Cerebral Blood Flow”. Kept off the family tree.

## Indications for use
CT Perfusion is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images obtained by cine imaging after the injection of contrast and to calculate the various perfusion related parameters (ie: regional cerebral blood flow, regional cerebral blood volume, time to peak). The results are displayed in user-friendly graphic format as parametric images. This software runs on the Advantage Workstation (AW) platform and will aid physicians in the assessment of the extent and type of brain perfusion disturbances.

Source page: https://510kreport.com/device/K993791
Methodology: https://510kreport.com/methodology