# K202213: syngo.CT Neuro Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 11, 2020 after 66 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: 7 generations back to K880965 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163284: syngo. CT Neuro Perfusion, Siemens Medical Solutions USA, Inc. (2017) Summary page 4.

## Indications for use
The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. It generates the following result volumes: • Cerebral blood flow (CBF) • Cerebral blood volume (CBV) • Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)) • Mean transit time (MTT) • Transit time to the center of the IRF (TMax) • Flow extraction product (permeability) • Temporal MIP • Temporal Average • Baseline Volume • Modified dynamic input data The software allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: • Lower signal intensity for CBF and CBV • Higher signal intensity for TTP, TTD, MTT, and TMax A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and may be helpful in therapy monitoring.

Source page: https://510kreport.com/device/K202213
Methodology: https://510kreport.com/methodology