# K083491: Neuroscape

- Pathway: 510(k) (Traditional)
- Applicant: Olea Medical
- Decided: Feb 19, 2009 after 86 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: 6 generations back to K896095 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063539: Nordic Image Control and Evaluation (Nice) Software, Version 2.1, Nordicicemedical AS (2007) Summary page 2.

## Indications for use
NEUROSCAPE is a PACS image management software intended for use with general purpose computing hardware to acquire and process images and data throughout a clinical environrnent. Data and images are acquired through DICOM compliant 'imaging devices and modalities. The system is'used in hospitals, imaging centers and radiologist practices by medically trained professionals. NEUROSCAPE accepts data from existing MRi systems, allows the selection of regions of interest as defined by a trained professional and provides a measurement of the areas or volumes associated with such selected regions. These measurements are normally used by the practitioner as an aid in the assessment of ischemic cerebral stroke patients. NEUROSCAPE is fully integrated with most existing medical image visualization applications. The system is a multi-platform software running on any Windows or 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/K083491
Methodology: https://510kreport.com/methodology