# K014011: Canvas N-Vas-D 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Vassol, Inc.
- Decided: Feb 5, 2002 after 62 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: 1 generation back to K923077 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923077: Advantage Windows 3D Option and Dentascan Option, GE Medical Systems (1993) Summary page 1.
- K924605: Magnetic Resonance Diagnostic Accessory, General Electric Co. (1993) Summary page 1.

## Indications for use
N-VAS-D is designed and intended for use as a supporting tool to non-invasive assessment of the vascular system. Intended purposes are: Supporting clinical diagnoses about the flow velocity and volume flow through the vascular system. Supporting subsequent clinical decision making purposes. Supporting clinical post-operation and follow-up evaluation about the flow velocity and volume flow throughout the vascular system. Supporting the use in the treatment planning using computer modeling of the vascular system.

Source page: https://510kreport.com/device/K014011
Methodology: https://510kreport.com/methodology