# K092925: 3D ASL

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jan 6, 2010 after 105 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: 8 generations back to K971684 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
5 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083147: Discovery MR450, Ge Medical Systems, LLC (2008) Summary page 1.
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Indications for use
3D ASL is a software option intended for use on GE 1.5T and 3.0T MR systems. It is indicated for magnetic resonance imaging of the brain. 3D ASL allows for generation of maps representing blood flow without the use of an exogenous contrast agent. 3D ASL utilizes water in arterial blood as an endogenous contrast media, to visualize tissue perfusion and evaluate cerebral blood flow (CBF). When interpreted by a trained physician, images generated by 3D ASL provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K092925
Methodology: https://510kreport.com/methodology