# K012154: Aurora Magnetic Resonance Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Imaging Technology, Inc.
- Decided: Sep 19, 2001 after 70 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K000356: C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580, Warepalmy Enterprise, LLC (Usa) (2000). Our OCR of the scanned summary read K000356, FDA’s number for C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580 (Warepalmy Enterprise, LLC (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “AURORA”. Kept off the family tree.

## Most influential descendants
- K032082: Aurora (2003), 3 descendants of its own
- K073425: Modification to Aurora Mri System (2008), 0 descendants of its own
- K052698: Modification to: Aurora (2005), 0 descendants of its own
- K032678: Modification to: Aurora (2003), 0 descendants of its own

## Indications for use
The AURORA MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (12), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The AURORA is a dedicated breast MRl system intended to be used as an adjunct to conventional breast screening methods. ® Anatomical Region: Breast tissue, axilla, and chest wall local to the breast ® Nucleus excited: Proton ® Diagnostic uses: 2D,3D T1- / T2-weighted imaging 1, 72, proton density measurements image processing ® Imaging capabilities: 2D Spin Echo (SE) 2D/3D Gradient Echo (GRE) Fat Suppression ® Imaging processing: Image Subtraction Imoge Filtering

Source page: https://510kreport.com/device/K012154
Methodology: https://510kreport.com/methodology