# K111161: Perfscape V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Nov 4, 2011 after 193 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 9 ancestors in all.
53 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090546: Modification to Nordicice Software, Nordicimaginglab AS (2009) Summary page 2.

## Most influential descendants
- K120196: Olea Sphere (2012), 51 descendants of its own
- K121447: Ischema View Rapid (2013), 29 descendants of its own
- K132095: Olea Sphere (2013), 20 descendants of its own
- K172477: iSchemaView RAPID (2018), 17 descendants of its own
- K152602: Olea Sphere V3.0 (2016), 17 descendants of its own

## Indications for use
PERESCAPE V2.O is a PACS system that allows the display, analysis and post-processing of dynamically acquired Magnetic Resonance (MRI) and Computed Tomography (CT) datasers to evaluate image intensity variations over time. PERESCAPE V2.O retrieves and accepts data from existing MRI and CT systems. Based on these data, PERESCAPE V2.O performs quality control checks, displays Diffusion Weighted Images (MRI only) and generates parametric maps such as Relative Blood Volume, Relative Blood Flow, Relative Mean Transit Time, Time to Peak, Impulse Response Time to Peak, permeability and leakage between intravascular and extracellular space (MRI only), and temporal Maximum Intensity Projection (CT only). PERFSCAPE V2.O also generates Diffusion Weighted Images and/or Diffusion Tensor Images (MRI only). These images, when interpreted by a trained physician, may yield clinically useful information. PEREFSCAPE V2.0 is compliant with the DICOM standard allowing the system to visualize medical images. The system is a multiplatform software running on Windows, Mac and Linux operating systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

Source page: https://510kreport.com/device/K111161
Methodology: https://510kreport.com/methodology