# K982536: Perfusion CT (Computed Tomography) Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Corp.
- Decided: Nov 24, 1998 after 126 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 K880965 (1988). 3 ancestors in all.
196 later devices descend from it; 2 cite it directly.
1 of 200 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875088: Xenon CT, Siemens Medical Solutions USA, Inc. (1988) Summary page 1.
- K910839: Ultimate 3000, Fonar Corp. (1991) Summary page 1.
- K880965: Somatom Plus, Siemens Medical Solutions USA, Inc. (1988). Our OCR of the scanned summary read K880963, FDA’s number for Hac Autology Centers Dispensing Kit for Fib.Con. (Buckman Co., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dynamic CT option (Somatom Plus)”.

## Most influential descendants
- K033832: Syngo Perfusion-CT (2003), 194 descendants of its own
- K050867: Syngo Body Perfusion-CT (2005), 192 descendants of its own
- K062351: Syngo Dual Energy (2006), 169 descendants of its own
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own

## Indications for use
Perfusion CT is an application software package that permits cerebral perfusion imaging based on dynamic CT images continuously acquired after the injection of contrast. The package allows visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion related parameters (i.e. relative cercbral blood flow, rclative cerebral blood volume, time to peak). By generating images of cerebral blood flow (CBF), cerebral blood volume (CBV), and local bolus timing (i.e. time to peak) from one set of dynamic CT images, Perfusion CT aids the physician in the assessment of the type and extent of cerebral perfusion disturbances. The software package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.

Source page: https://510kreport.com/device/K982536
Methodology: https://510kreport.com/methodology