# K962627: Clinical Phosphorus Spectroscopy Option/Magnetom Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 3, 1997 after 272 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Proton Spectroscopy Option for the MAGNETOM VISION: named in the summary without a submission number
- (no number) Spectroscopy Option for the MAGNETOM 63SP: named in the summary without a submission number

## Most influential descendants
- K042718: 13C/1H Occipital Headcoil for Magnetom Allegra (2004), 1 descendant of its own
- K042617: 31P/1H Headcoil for Magnetom Allegra (2004), 1 descendant of its own
- K080820: Tem 3002G- HN Dual Tune Head Coil (2008), 0 descendants of its own

## Indications for use
Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.

Source page: https://510kreport.com/device/K962627
Methodology: https://510kreport.com/methodology