# K091444: Perfscape

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Jul 20, 2009 after 66 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911667 (1991). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080762: IB Neuro, Version 1.0, Imaging Biometrics, LLC (2008) Summary page 2.

## Indications for use
PERFSCAPE allows the post-processing and display of dynamically acquired Magnetic Resonance datasets to evaluate image intensity variations over time. PERFSCAPE retrieves and accepts data from existing MRI systems. Based on these data, PERFSCAPE performs quality control checks, displays Diffusion Weighted Images and generates parametric perfusion maps such as Relative Cerebral Blood Volume (rCBV), Relative Cerebral Blood Flow (rCBF), Relative Mean Transit Time (rMTT), Time to Peak (TTP) and Impulse Response Time to Peak (TMAX). These images when interpreted by a trained physician may yield information useful in clinical applications. PERFSCAPE is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multi-platform software running on any Windows, Mac and Linux operating systems.

Source page: https://510kreport.com/device/K091444
Methodology: https://510kreport.com/methodology