# K071506: Echelon Spectroscopy Package

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jun 28, 2007 after 27 days
- Product code: LNI (System, Nuclear Magnetic Resonance Spectroscopic)
- 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: 2 generations back to K930265 (1995). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991568: MR Spectroscopy Package, Philips Medical Systems (Cleveland), Inc. (1999) Summary page 1.

## Most influential descendants
- K093044: Oasis Mri System (2010), 4 descendants of its own
- K192851: OASIS MRI System (2020), 3 descendants of its own
- K202030: OASIS MRI System (2020), 2 descendants of its own
- K211406: OASIS MRI System (2021), 1 descendant of its own
- K240571: OASIS MRI System (2024), 0 descendants of its own

## Indications for use
The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis. Anatomical Region: Head, Whole Body Nucleus excited: 1H

Source page: https://510kreport.com/device/K071506
Methodology: https://510kreport.com/methodology