# K063505: Visualase Envision Software System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Dec 12, 2006 after 22 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: 2 generations back to K913475 (1991). 3 ancestors in all.
27 later devices descend from it; 1 cites it directly.
2 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.

## Most influential descendants
- K071328: Visualase Thermal Therapy System (2007), 26 descendants of its own
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own

## Indications for use
The Visualase ENVISION workstation is intended to retrieve, store, process, and display temporally dynamic magnetic resonance (MR) data from compatible scanners. The software is capable of analyzing either temporal changes in image intensity as is useful in, for example, dynamic contrast enhancement studies, or temporal changes in complex phase of image data as is useful in, for example, in phase contrast angiography or in determinations of dynamic phase changes related to temperature changes in soft tissues. The image data may be manipulated and viewed in a number of different ways and the value of data at certain selected points may be monitored and/or displayed over time. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of a diagnosis, intervention, or course of treatment. Patient management decisions should not be made solely on the basis of Visualase ENVISION analysis.

Source page: https://510kreport.com/device/K063505
Methodology: https://510kreport.com/methodology