# K023686: Aurora MR-Guided Interventional System

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Imaging Technology, Inc.
- Decided: Jan 29, 2003 after 89 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 K000832 (2000). 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)
- K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160, Mri Devices Corp. (2001) Summary page 1.
- K000832: Sterotactic Localization Device (SLD), Philips Medical Systems North America, Inc. (2000) Summary page 1.

## Indications for use
The Aurora@ MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinician.

Source page: https://510kreport.com/device/K023686
Methodology: https://510kreport.com/methodology