# K991568: MR Spectroscopy Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jul 19, 1999 after 75 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: 1 generation back to K930265 (1995). 2 ancestors in all.
6 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)
- K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT, GE Medical Systems (1995) Summary page 2.
- K951650: Clinical Proton Spectroscopy Option, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.

## Most influential descendants
- K071506: Echelon Spectroscopy Package (2007), 5 descendants of its own
- 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

## Indications for use
The Picker 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. This package is indicated for use as follows: Anatomical region: Head, whole body Nuclei Excited: 'H

Source page: https://510kreport.com/device/K991568
Methodology: https://510kreport.com/methodology